FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1031701
·
Received April 18, 2008
Report
- Report Number
- 3015876-2008-00360
- Event Type
- Malfunction
- Date Received
- April 18, 2008
- Date of Event
- March 20, 2008
- Report Date
- March 20, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE AND OBSERVED THAT IT WOULD NOT OPERATE ON AC POWER. PHYSIO REPLACED THE POWER SUPPLY ASSEMBLY AND THEN OBSERVED PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, THE DEVICE WILL NOT OPERATE ON AC AND IT WILL NOT CHARGE THE BATTERY. THERE WERE NO ADVERSE AFFECTS REPORTED AS A RESULT OF THE DEVICE USE.
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 |