FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 9 DEFIBRILLATOR/MONITOR
MDR report key: 1191369
·
Received September 26, 2008
Report
- Report Number
- 3015876-2008-01385
- Event Type
- Malfunction
- Date Received
- September 26, 2008
- Date of Event
- August 28, 2008
- Report Date
- August 28, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K881153
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL ADVISED THE CUSTOMER THAT IT COULD BE A PROBLEM WITH THE POWER CONVERSION PCB. THE CUSTOMER LATER CONFIRMED THAT REPLACING THE POWER CONVERSION PCB BOARD RESOLVED THE REPORTED FAILURE. THE REMOVED BOARD WILL 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 ALWAYS CHARGE UP TO THE SELECTED VALUE, ESPECIALLY AT HIGHER LEVELS. THERE WERE NO REPORTS OF PT 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 |