FDA Adverse Event
Other
Summary report: N
STRYKER LIFEPAK 35
MDR report key: 23751166
·
Received December 8, 2025
Report
- Report Number
- MW5180144
- Event Type
- Other
- Date Received
- December 8, 2025
- Report Date
- December 2, 2025
- Manufacturer
- STRYKER/PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
LIFEPAK 35 WOULD NOT DISPLAY AN EKG (ELECTROCARDIOGRAM), AFTER POWER CYCLING THE DEVICE, THE EKG WAS PROPERLY DISPLAYED. DEVICE WAS RETURNED TO STRYKER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2797497 | STRYKER LIFEPAK 35 | AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | MKJ | STRYKER/PHYSIO-CONTROL, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |