FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1070828
·
Received July 3, 2008
Report
- Report Number
- 3015876-2008-00753
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- June 4, 2008
- Report Date
- June 4, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL SUPPLIED TROUBLESHOOTING ASSISTANCE AND PARTS INFO TO CUSTOMER FOR REPAIR.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, THE DEVICE IS PLUGGED INTO AC POWER BUT DOES NOT HAVE AC MAINS LIGHT ON AND IS BEEPING FROM THE AC LOSS ALERT. THERE WAS NO PATIENT ASSOCIATED WITH THE REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 20 DEFIBRILLATOR/MONITOR | LDD | PHYSIO-CONTROL, INC. | 20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |