HEARTSTART XL+ DEFIBRILLATOR/MONITOR
Report
- Report Number
- 3030677-2021-15975
- Event Type
- Malfunction
- Date Received
- November 29, 2021
- Date of Event
- November 1, 2021
- Manufacturer
- PHILIPS NORTH AMERICA LLC
- Product Code
- MKJ
- UDI-DI
- 00884838023680
- PMA / PMN Number
- K110825
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE CUSTOMER REPORTED THAT THE DEVICE FAILED ONE OF THE CHECKS WHILE CONDUCTING ROUTINE MAINTENANCE. WHEN THE CUSTOMER TRIED TO SHOCK THE DEVICE IN SYNC MODE, THE PRESSED BUTTON WOULDN¿T REGISTER. THE CUSTOMER KEPT THE BUTTON PRESSED AS SPECIFIED, BUT THE DEVICE WOULDN¿T SHOCK. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS RECEIVED BY BENCH REPAIR ON (B)(6)2021. THE NOTED FAILURE WAS IDENTIFIED DURING INSPECTION OF THE DEVICE BY AN AUTHORIZED BENCH TECHNICIAN. AS A RESULT OF THE ISSUE, IT WAS DETERMINED THAT THE MULTIPLE PARTS WOULD NEED TO BE REPLACED. UPON CONCLUSION OF THE EVALUATION, IT WAS DETERMINED THAT THIS WAS A MALFUNCTION OF THE PROCESSOR PCA AND HIF PCA. THE PROCESSOR PCA AND HIF PCA WERE REPLACED TO RESOLVE THE REPORTED ISSUE AND THE DEVICE WAS SCHEDULED TO BE RETURNED TO THE CUSTOMER SITE. NO FURTHER EVALUATION IS REQUIRED AT THIS TIME.
THE CUSTOMER REPORTED THAT THE DEVICE FAILED ONE OF THE CHECKS WHILE CONDUCTING ROUTINE MAINTENANCE. WHEN THE CUSTOMER TRIED TO SHOCK THE DEVICE IN SYNC MODE, THE PRESSED BUTTON WOULDN¿T REGISTER. THE CUSTOMER KEPT THE BUTTON PRESSED AS SPECIFIED, BUT THE DEVICE WOULDN¿T SHOCK. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1778310 | HEARTSTART XL+ DEFIBRILLATOR/MONITOR | DEFIBRILLATOR | MKJ | PHILIPS NORTH AMERICA LLC | 861290 | 00884838023680 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |