Device product
Philips HeartStart MRx Monitor/Defibrillator with CO2/EtCO2 Measurement The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. The HeartStart MRx EtCO2 Option monitors carbon dioxide (CO2) and measures end-tidal carbon dioxide (EtCO2). The option provides an EtCO2 value and a CO2 waveform on the devices display.
Z-0570-2014
Product summary
- Event
- Event 67046
- Status
- Terminated
- Classification
- Class II
- Quantity
- 18,529 units
- Official record key
device-enforcement:Z-0570-2014
Official wording
Reason: MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 level falls below 7.6 mmHg
Code information: Software versions: F.02, R.02, 9.xx or any earlier versions Addendum Models: M3532A, M3535A, M3536AM, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 M3535A- HeartStart MRx Defibrillator Monitor M3536A- HeartStart MRx Defibrillator Monitor EtC02 Options A04 A05 A06 All M3532A Upgrade
Distribution pattern: US Nationwide and OUS.
Derived failure modes
-
Unknown
MRx defibrillator displays a -?- for EtCO2 and does not display EtCO2 values when patient CO2 level falls below 7.6 mmHg