Device product
LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 331706400001 / 99425-000025 / 885074698953 LIFEPAK 1000: The defibrillator is to be used in AED mode only on patients who are in cardiopulmonary arrest. The patient must be unresponsive, not breathing normally, and showing no signs of circulation. ECG monitoring is for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring.
Z-2498-2025
Product summary
- Event
- Event 96949
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-2498-2025
Official wording
Reason: Due to required inspections not being performed on products/units that have gone through servicing.
Code information: Part / Catalog Numbers / UDI-DI code / Serial Number: 320371500023 / 99425-000025 / 885074698953 / 35942190 320371500229 / 99425-000025 / 885074698953 / 41012118 331706400001 / 99425-000025 / 885074698953 / 48988273
Distribution pattern: U.S. Nationwide distribution in the states of CO and MT.
Derived failure modes
-
Unknown
Due to required inspections not being performed on products/units that have gone through servicing.