DUAL CHAMBER TEMPORARY PACEMAKER
Report
- Report Number
- 3004593495-2019-00685
- Event Type
- Malfunction
- Date Received
- July 12, 2019
- Date of Event
- July 3, 2019
- Report Date
- August 13, 2019
- Manufacturer
- PLEXUS MANUFACTURING SDN. BHD
- Product Code
- DTE
- UDI-DI
- 00643169508767
- PMA / PMN Number
- K150246
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PRODUCT ANALYSIS: ANALYSIS CONFIRMED THE CUSTOMER COMMENT, THE MAIN PRINTED CIRCUIT BOARD(PCB) WAS DEEMED TO BE INTERMITTENT AND IT WAS ADDITIONALLY NOTED THAT C277 ON THE MAIN PCB WAS DAMAGED. IT WAS ALSO REPORTED THAT LARGE AMOUNTS OF ADHESIVE WERE PRESENT ON THE BACK OF THE LOWER CASE, ONE CASE SCREW WAS CONTAMINATED AND BOTH WIRES ON THE LIQUID CRYSTAL DISPLAY WERE PINCHED BUT NOT COMPROMISED. ALL FOUND DEFECTIVE PARTS WERE REPLACED AND ALL OTHER IDENTIFIED ISSUES WERE RESOLVED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE BACKLIGHTING FEATURE OF THE EXTERNAL PULSE GENERATOR (EPG) WAS NOT ILLUMINATING. THE BATTERIES WERE REPLACED, BUT THE ISSUE REMAINED. THE EPG REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS FURTHER REPORTED THAT THE EPG WAS RETURNED FOR SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 578333 | DUAL CHAMBER TEMPORARY PACEMAKER | PULSE-GENERATOR, PACEMAKER, EXTERNAL | DTE | PLEXUS MANUFACTURING SDN. BHD | 5392 | 00643169508767 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |