Core noun
Failure mode assignments
Deterministic labels derived from preserved recall-reason text.
Indexed record set
89,789 assignments
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- Mode
- Device software or design
- Product
- UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Numbers: DxC 660i: A64871; DxC 680i: A64903; DxC 860i: A64935; DxC 880i: A59102. The DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software anomaly
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- Mode
- Device software or design
- Product
- Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software anomaly
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- Mode
- Device software or design
- Product
- bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413481 Software update for an instrument which is most commonly used to isolate and recover specimens drawn from adult and older pediatric patients that are acutely ill with signs and symptoms suggestive of blood stream infection, which can be due to a variety of sources including lung, abdomen, urinary tract, endovascular, and skin.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software miscommunication
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- Mode
- Device software or design
- Product
- DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software will
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- Mode
- Device software or design
- Product
- Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement of organ uptake and circulating radioactivity.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software Revision 1.22 in January 2011. The error
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- Mode
- Device software or design
- Product
- UniCel¿ DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel¿ DxC Synchron¿ Clinical Systems are fully automated, computercontrolled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent).
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software installed. If the Shuttle to Barcode Reader becomes misaligned, the Operator will
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- Mode
- Device software or design
- Product
- V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for Use for the V Series include the monitoring of the following human physiological parameters: ECG waveform derived from 3, 5, 6 and 12 lead measurements; Heart Rate; Pulse Oximetry (SpO2); ST Segment Analysis; Arrhythmia Detection; Non Invasive Blood Pressure (NIBP); Invasive Blood Pressure (IBP); Cardiac Output (CO); Respiratory Gasses; Respiration Rate; and Temperature. The V Series Monitor has the capability of performing IV Drug and Hemodynamic Calculations and interfacing with network devices. The target populations are adult, pediatric and neonate with the exception of: Arrhythmia detection and ST Segment Analysis, for which the target populations are adult and pediatric only; IV Drug Calculations for which the target population is adult only; and Cardiac Output for which the target population is adult and pediatric only.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software anomalies
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- Mode
- Device software or design
- Product
- Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San Jose, CA Cisco HealthPresence, version 2 is intended for remote consultation of patients with a healthcare provider. Cisco HealthPresence enables remote collaboration between a physician and a patient by providing: high-definition video and advanced audio; transmission and display of third-party medical device data; integration with third party EMR: scheduling: and other software applications for remote consultations and exams. Cisco Health Presence is not intended for use in emergency situations. Cisco HealthPresence is not intended for use in active patient monitoring or alarming.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software anomaly may result in incorrect
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- Mode
- Device software or design
- Product
- The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software version 4.0.0xx379 does not prevent
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- Mode
- Device software or design
- Product
- Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software issue
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- Mode
- Device software or design
- Product
- smiths medical Medfusion Model 4000 syringe pump
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software versions, may
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- Mode
- Device software or design
- Product
- Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay - PlateletMapping ADP & AA (07-014), PlateletMapping ADP (07-015), PlateletMapping AA (07-016). Issue occurs when Platelet Mapping Assay results from a TEG 5000 analyzer are viewed using TEG Manager Software (versions 1.1-4.3.1)
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software, incorrect
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- Mode
- Device software or design
- Product
- smiths medical Medfusion Model 3500 Syringe pump
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software versions before v6.0.0, may
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- Mode
- Device software or design
- Product
- The Hospira MedNet Medication Management Suite (MMS). Product Usage: The Hospira MedNet Medication Management Suite (MMS) is intended to facilitate networked communication between MMS compatible computer systems and Hospira infusion pumps. The MMS provides trained healthcare professionals with the capability to send, receive, report, and store information from interfaced external systems, and to configure and edit infusion programming parameters. The MMS is intended to provide a way to automate the programming of infusion parameters, thereby decreasing the amount of manual steps necessary to enter infusion data. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physicians orders.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software defect
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- Mode
- Device software or design
- Product
- Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software identified software anomaly
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- Mode
- Device software or design
- Product
- SOMATOM Confidence with software syngo.CT VB20 Model #10590100
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in
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- Mode
- Device software or design
- Product
- syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software version makes an automatic change in laser configuration settings for "markerless workflow" which may
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- Mode
- Device software or design
- Product
- SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in
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- Mode
- Device software or design
- Product
- SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in
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- Mode
- Device software or design
- Product
- SOMATOM Force with software syngo.CT VB20 Model #10742326
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in
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- Mode
- Device software or design
- Product
- SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in
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- Mode
- Device software or design
- Product
- GE Healthcare, LOGIQ S8 Ultrasound System The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software of the LOGIQ S8 system. This issue
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- Mode
- Device software or design
- Product
- syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Up Model Number 11061620. Running on servers with syngo.via VB60 software after upgrade and CT scanners with syngo.CT VA40A after upgrade.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software version makes an automatic change in laser configuration settings for "markerless workflow" which may
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- Mode
- Device software or design
- Product
- SOMATOM Drive with software syngo.CT VB20 Model #10431700
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in
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- Mode
- Device software or design
- Product
- Infinite 200 PRO in vitro diagnostic. Product Usage: The Tecan Infinite 200 PRO is a multifunctional microplate reader with injector option. The Infinite 200 PRO provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The Infinite 200 PRO has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384 well microplates conforming to the ANS/SBS standards.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- firmware bug causes incorrect