FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER
MDR report key: 1232113
·
Received November 4, 2008
Report
- Report Number
- 3015876-2008-01576
- Event Type
- Malfunction
- Date Received
- November 4, 2008
- Date of Event
- October 6, 2008
- Report Date
- October 6, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K890079
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL SUPPLIED TROUBLESHOOTING ASSISTANCE, AND PARTS INFORMATION FOR DEVICE REPAIR. THE REPORTERS STATED THE DEVICE HAS BEEN REPLACED.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, THE DEVICE WILL NOT POWER UP WITH EITHER BATTERIES OR AC AUXILIARY POWER SUPPLY. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 10 DEFIBRILLATOR/MONITOR/PACEMAKER | LDD | PHYSIO-CONTROL, INC. | 10 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |