FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 9 DEFIBRILLATOR/MONITOR
MDR report key: 1027277
·
Received April 8, 2008
Report
- Report Number
- 3015876-2008-00276
- Event Type
- Malfunction
- Date Received
- April 8, 2008
- Date of Event
- January 16, 2008
- Report Date
- January 16, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K881153
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT A FAILED IC CHIP, DESIGNATOR U28 ON THE MAIN PCB ASSEMBLY WOULD CAUSE A FAILURE OF THE DEFIBRILLATOR TO CHARGE COMPLETELY AT 200 JOULES AND HIGHER. THE DEFIBRILLATOR ALSO FAILED TO DISCHARGE. PHYSIO REPLACED U28 AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WON'T CHARGE TO 200J FOR DAILY TEST. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 9 DEFIBRILLATOR/MONITOR | LDD | PHYSIO-CONTROL, INC. | 9 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |