Device product
Philips HeartStart XL Defibrillator/Monitor (Model number M4735A) - Product Usage: is for use in the hospital by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, or defibrillation. It must be used by or on the order of a physician.
Z-2053-2020
Product summary
- Event
- Event 85147
- Status
- Terminated
- Classification
- Class II
- Quantity
- 94,034 units
- Official record key
device-enforcement:Z-2053-2020
Official wording
Reason: The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not perform the selected function;3) The device may deliver a shock with an energy level different than the setting selected by the user. In any of these scenarios, appropriate therapy delivery may be delayed.
Code information: All units. Product has been discontinued.
Distribution pattern: Worldwide distribution - US Nationwide distribution.
Derived failure modes
-
Unknown
The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not perform the selected function;3) The device may deliver a shock with an energy level different than the setting selected by the user. In any of these scenarios, appropriate therapy delivery may be delayed.