Device product
Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Product Usage: is intended to be used with the M3536A MRx in EMS environments.
Z-1342-2020
Product summary
- Event
- Event 84796
- Status
- Terminated
- Classification
- Class II
- Quantity
- 43 units
- Official record key
device-enforcement:Z-1342-2020
Official wording
Reason: M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments
Code information: All
Distribution pattern: International distribution in the countries of Austria, Germany, Netherlands, Norway, Poland, Switzerland
Derived failure modes
-
Unknown
M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments