LIFEPAK(R) CR2 DEFIBRILLATOR
Report
- Report Number
- 0003015876-2023-01043
- Event Type
- Death
- Date Received
- June 7, 2023
- Date of Event
- April 27, 2023
- Report Date
- July 28, 2023
- Manufacturer
- PHYSIO-CONTROL, INC. - 3015876
- Product Code
- MKJ
- UDI-DI
- 00883873824139
- PMA / PMN Number
- P170018
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- 003
Narratives
THE CUSTOMER PROVIDED STRYKER WITH ALL THE AVAILABLE PATIENT INFORMATION. PATIENT FIELDS IN WHICH INFORMATION WAS NOT PROVIDED WERE INTENTIONALLY LEFT BLANK. THE CUSTOMER RECEIVED A REPLACEMENT LID AND BATTERY. THE DEVICE OR THE LID WAS NOT RETURNED TO STRYKER FOR EVALUATION. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. STRYKER PERFORMED A CLINICAL REVIEW OF THE REPORTED EVENT AND IT WAS DETERMINED THAT IS UNKNOWN IF THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED OUTCOME. THIS BECAUSE THE ECG WAS UNAVAILABLE, AND IT IS UNKNOWN IF THE PATIENT WAS IN A SHOCKABLE RHYTHM AT THE TIME OF THE EVENT. H3 OTHER TEXT : NOT RETURNED TO MANUFACTURER.
STRYKER DETERMINED THAT THE DEVICE NOT POWERING ON AND THE READINESS INDICATOR NOT FLASHING WAS LIKELY CAUSED BY A DEPLETED BATTERY DUE TO THE MISSING MAGNET. THE ROOT CAUSE OF THE MISSING MAGNET COULD NOT BE DETERMINED.
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON DURING A PATIENT EVENT. I ADDITION, THE CUSTOMER ADVISED THAT THEIR DEVICE WAS MISSING THE MAGNET FROM THE LID OF THE DEVICE. IN THIS STATE THE DEVICE WILL NOT TURN ON AUTOMATICALLY WHEN THE LID IS ACTIVATED, WHICH CAN CAUSE A DELAY IN DEFIBRILLATION THERAPY IF NEEDED OR MAY LEAD TO USE ERROR RESULTING IN A FAILURE TO DELIVER DEFIBRILLATION. ANOTHER DEVICE WAS LOCATED TO CONTINUE PATIENT CARE, HOWEVER, THE PATIENT DID NOT SURVIVE.
THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE WOULD NOT POWER ON DURING A PATIENT EVENT. I ADDITION, THE CUSTOMER ADVISED THAT THEIR DEVICE WAS MISSING THE MAGNET FROM THE LID OF THE DEVICE. IN THIS STATE THE DEVICE WILL NOT TURN ON AUTOMATICALLY WHEN THE LID IS ACTIVATED, WHICH CAN CAUSE A DELAY IN DEFIBRILLATION THERAPY IF NEEDED OR MAY LEAD TO USE ERROR RESULTING IN A FAILURE TO DELIVER DEFIBRILLATION. ANOTHER DEVICE WAS LOCATED TO CONTINUE PATIENT CARE, HOWEVER, THE PATIENT DID NOT SURVIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1368305 | LIFEPAK(R) CR2 DEFIBRILLATOR | AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | MKJ | PHYSIO-CONTROL, INC. - 3015876 | CR2 | 00883873824139 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death |