Device product
Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates in a hospital environment and during patient transport inside and outside of the hospital environment.
Z-0545-2021
Product summary
- Event
- Event 86848
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units OUS
- Official record key
device-enforcement:Z-0545-2021
Official wording
Reason: Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.
Code information: Serial Numbers: DE73602213 DE73602577 UDI: (01)00884838000278(21)DE73602213 (01)00884838000278(21)DE73602577
Distribution pattern: Worldwide distribution - US Nationwide distribution in the state of SD and the countries of China, England, Germany, Hong Kong, Portugal.
Derived failure modes
-
Unknown
Speakers on IntelliVue X2 and IntelliVue MP2 may fail, identified by the display of a Speaker Malfunct. INOP or by the absence of audible sound, may result in delayed treatment of the patient.