FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1070359
·
Received June 30, 2008
Report
- Report Number
- 3015876-2008-00642
- Event Type
- Malfunction
- Date Received
- June 30, 2008
- Date of Event
- June 3, 2008
- Report Date
- June 3, 2008
- Manufacturer
- PHYSIO-CONTROL, INC
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL SUPPLIED TROUBLESHOOTING ASSISTANCE AND PARTS INFORMATION FOR REPAIR.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, THE DEVICE FAILS THE USER TEST AND DISPLAYS THE MESSAGE "ABNORMAL SHOCK". CUSTOMER WANTS TROUBLESHOOTING ASSISTANCE AND PARTS INFORMATION TO REPAIR DEVICE.
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 | UNK |