FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1191426
·
Received September 26, 2008
Report
- Report Number
- 3015876-2008-01419
- Event Type
- Malfunction
- Date Received
- September 26, 2008
- Date of Event
- July 28, 2008
- Report Date
- July 28, 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE HOSPITAL'S BIOMED REPLACED THE DEVICE'S THERAPY CABLE AND COMPLETED A PERFORMANCE INSPECTION PROCEDURE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS PLACED BACK INTO SERVICE. THE REMOVED THERAPY CABLE WAS DISCARDED BY THE CUSTOMER AND WILL NOT BE AVAILABLE FOR EVAL. THE ROOT CAUSE OF THE REPORTED FAILURE CANNOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WOULD CONTINUALLY RECEIVE THE CONNECT CABLE MESSAGE WHEN THE DEVICE WAS POWERED ON. THERE WAS NO PT USE ASSOCIATED WITH THIS 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 |