FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 9 DEFIBRILLATOR/MONITOR
MDR report key: 1070765
·
Received July 3, 2008
Report
- Report Number
- 3015876-2008-00757
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- June 6, 2008
- Report Date
- June 6, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K881153
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL RECOMMENDED CUSTOMER REPLACING THE POWER CONVERSION PCB. THE CUSTOMER LATER CONFIRMED THAT THEY REPLACED THE POWER CONVERSION PCB AND THE DEVICE IS WORKING PROPERLY. THE REPLACED POWER CONVERSION PCB WIL NOT BE RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE ROOT CAUSE OF THE REPORTED FAILURE CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WILL NOT STAY POWERED ON AND A SERVICE INDICATOR IS BEING DISPLAYED INTERMITTENTLY. THERE WAS NO PATIENT USE ASSOCIATED WITH THIS 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 |