Device product
The Cogent Hemodynamic Monitoring System. REF58400-000, GTIN 00840619099459; REF 58400-000R, GTIN 0087709094314; REF 58403, GTIN 00840619079505; REF 58401, GTIN 00840619079499 - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician. The target population includes Critical Care Patients, Trauma Patients, and Cardiac Surgery Patients.
Z-1927-2020
Product summary
- Event
- Event 85329
- Status
- Terminated
- Classification
- Class II
- Quantity
- 123 units
- Official record key
device-enforcement:Z-1927-2020
Official wording
Reason: Firm identified software issues which leads to the patient ID and patient information not being stored in the system.
Code information: All serial numbers of Cogent HMS, List Number(s): 58400-000; 58400-000R; 58403-000; 58401-000 with Software Versions 1.3.3.42 and prior are impacted.
Distribution pattern: US Nationwide distribution including in the states of AR, CA, FL, IL, MD, NC, NE, NY, TX, VT, WA and WI.
Derived failure modes
-
Unknown
Firm identified software issues which leads to the patient ID and patient information not being stored in the system.