HEARTSTART MRX MONITOR/DEFIB
Report
- Report Number
- 3030677-2024-00785
- Event Type
- Malfunction
- Date Received
- March 1, 2024
- Date of Event
- February 23, 2024
- Manufacturer
- PHILIPS NORTH AMERICA LLC
- Product Code
- MKJ
- UDI-DI
- 00884838000018
- PMA / PMN Number
- K031187
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H3 OTHER TEXT : REMOTE SUPPORT PROVIDED.
THIS REPORT IS BASED ON INFORMATION PROVIDED BY PHILIPS REMOTE SERVICE ENGINEER (RSE) PERSONNEL AND HAS BEEN INVESTIGATED BY THE PHILIPS COMPLAINT HANDLING TEAM. PHILIPS RECEIVED A COMPLAINT ON THE MRX INDICATING THAT IT HAS A BATTERY ERROR. THE CUSTOMER WORKED WITH THE RSE. THE CUSTOMER EVALUATION DETERMINED THE BATTERY IS DEPLETED. THE DEVICE NEEDS A BATTERY. HOWEVER, THE DEVICE IS END-OF-LIFE (EOL) SINCE 31 DECEMBER 2023 AND NO PARTS FROM PHILIPS ARE AVAILABLE. THE CUSTOMER WILL TRY TO FIND A BATTERY FROM ANOTHER SUPPLIER. NO FURTHER ACTION AT THIS TIME. BASED ON THE INFORMATION AVAILABLE AND THE TESTING CONDUCTED, THE CAUSE OF THE REPORTED PROBLEM WAS A BATTERY. THE REPORTED PROBLEM WAS CONFIRMED BY THE CUSTOMER. THE DEVICE WAS EVALUATED BY THE CUSTOMER AND A BATTERY REPLACEMENT IS NEEDED BUT THE DEVICE IS EOL. THE CUSTOMER WILL TRY TO FIND A BATTERY. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309838 | HEARTSTART MRX MONITOR/DEFIB | DEFIBRILLATOR | MKJ | PHILIPS NORTH AMERICA LLC | M3535A | 00884838000018 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |