Device product
Infant Warmer System (IWS)
Z-2323-2017
Product summary
- Event
- Event 77287
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34986
- Official record key
device-enforcement:Z-2323-2017
Official wording
Reason: GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could fall onto the bed if the Heater Head assembly has been improperly serviced. This situation can be clinically hazardous because thermal injury to a patient could result. Two injuries have been reported as a result of this issue.
Code information: Medical device listing number: D103053, D103054, D103056, D103057, D183529
Distribution pattern: Worldwide Distribution - USA (nationwide) Distribution.
Derived failure modes
-
Unknown
GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could fall onto the bed if the Heater Head assembly has been improperly serviced. This situation can be clinically hazardous because thermal injury to a patient could result. Two injuries have been reported as a result of this issue.