FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER
MDR report key: 1052210
·
Received May 21, 2008
Report
- Report Number
- 3015876-2008-00521
- Event Type
- Malfunction
- Date Received
- May 21, 2008
- Date of Event
- April 24, 2008
- Report Date
- April 24, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K902288
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL SUPPLIED PART INFO FOR POWER CONVERSION PCB ASSEMBLY REPAIR KIT TO CUSTOMER FOR REPAIR.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, THE DEVICE WON'T STAY POWERED UP. THERE WERE NO REPORTS OF ANY ADVERSE EVENTS AS A RESULT OF THE DEVICE USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 9P DEFIBRILLATOR/MONITOR/PACEMAKER | LDD | PHYSIO-CONTROL, INC. | 9P | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |