HEART START XL
Report
- Report Number
- 3030677-2023-04200
- Event Type
- Malfunction
- Date Received
- October 22, 2023
- Date of Event
- October 6, 2023
- Manufacturer
- PHILIPS NORTH AMERICA LLC
- Product Code
- MKJ
- PMA / PMN Number
- K021453
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS SERVICE REPRESENTATIVE AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE HEARTSTART XL. THE SERVICE TECHNICIAN DOING A PREVENTIVE MAINTENANCE FOUND THE DEVICE FAILING TESTING DUE TO A DEPLETED BATTERY. THERE WAS NO PATIENT INVOLVEMENT. THE SERVICE TECHNICIAN DOING A PREVENTIVE MAINTENANCE FOUND THE DEVICE FAILING TESTING DUE TO A DEPLETED BATTERY. THE DEVICE NEEDS A BATTERY. HOWEVER, SINCE THE DEVICE IS END-OF-LIFE (EOL) SINCE 31DEC2017, PARTS THROUGH PHILIPS ARE NOT AVAILABLE. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS A DEPLETED BATTERY. THE REPORTED PROBLEM WAS CONFIRMED. THE CUSTOMER IS SEEKING A REPLACEMENT BATTERY. ONCE THE BATTERY IS REPLACED THE DEVICE WILL BE FULLY OPERATIONAL. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME.
IT WAS REPORTED TO PHILIPS THAT THE DEVICE FAILED TESTING DUE TO A DEPLETED BATTERY. THERE WAS NO PATIENT INVOLVEMENT.
IT WAS REPORTED TO PHILIPS THAT THE DEVICE BATTERY IS INSUFFICIENT. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1272315 | HEART START XL | DEFIBRILLATOR | MKJ | PHILIPS NORTH AMERICA LLC | M4735A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |