FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1120585
·
Received August 12, 2008
Report
- Report Number
- 3015876-2008-00929
- Event Type
- Malfunction
- Date Received
- August 12, 2008
- Date of Event
- July 16, 2008
- Report Date
- July 16, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL WILL EVALUATE THE DEVICE UPON RECEIPT FROM THE CUSTOMER. PHYSIO-CONTROL WILL SUBMIT SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED BY 21 CFR 803.56.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, THE DEVICE WILL NOT FUNCTION ON BATTERY POWER. 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 |