Device product
Giraffe Incubator infant warmer
Z-0541-2020
Product summary
- Event
- Event 84077
- Status
- Terminated
- Classification
- Class I
- Quantity
- 19425 units
- Official record key
device-enforcement:Z-0541-2020
Official wording
Reason: Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.
Code information: Model Numbers: 6651-XXXX-XXX 2074921-00X-XXXXXX M1050206 M1050207 M1136120 M1136222 M1136226 M1138367 M1145526 M1145527 M1146091 M1146092 M1148634 M1161351 M1161353 M1161357 M1206149 M1235958 Updated 6/3/2021 - All model numbers and units are affected.
Distribution pattern: worldwide
Derived failure modes
-
Unknown
Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall.