FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 9 DEFIBRILLATOR/MONITOR
MDR report key: 1082727
·
Received July 23, 2008
Report
- Report Number
- 3015876-2008-00819
- Event Type
- Malfunction
- Date Received
- July 23, 2008
- Date of Event
- June 23, 2008
- Report Date
- June 23, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K881153
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL REPLACED THE POWER CONVERSION PCB ASSEMBLY AND THEN OBSERVICE PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REPLACED PCB ASSEMBLY AND DETERMINED THAT ELECTROLYTE FROM TWO CAPACITORS, DESIGNATORS C7 AND C25 HAD LEAKED ONTO THE PCB SURFACE IN THE AREA OF THE CHARGE/ENERGY EVALUATION CIRCUITRY, CAUSING INTERMITTENT OPERATION OF THE CIRCUITRY.
Description of Event or Problem · 1
WHILE PERFORMING NORMAL PERIODIC INSPECTION AND MAINTENANCE OF CUSTOMER'S DEVICE, PHYSIO-CONTROL OBSERVED THAT DEFIBRILLATOR INTERMITTENTLY WOULD NOT CHARGE TO ENERGY LEVELS BELOW 100 JOULES.
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 |