FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1051207
·
Received May 23, 2008
Report
- Report Number
- 3015876-2008-00530
- Event Type
- Malfunction
- Date Received
- May 23, 2008
- Date of Event
- April 23, 2008
- Report Date
- April 23, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K012274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL EVALUATED THE DEVICE BUT DID NOT VERIFY THE REPORTED INTERMITTENT FAILURE. PHYSIO REPLACED THE POWER SUPPLY ASSEMBLY AND THEN PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WOULD NOT OPERATE ON BATTERY POWER. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED EVENT.
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 |