FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 1082134
·
Received July 25, 2008
Report
- Report Number
- 3015876-2008-00839
- Event Type
- Malfunction
- Date Received
- July 25, 2008
- Date of Event
- June 27, 2008
- Report Date
- June 27, 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
PHYSIO-CONTROL PROVIDED CUSTOMER WITH PART NUMBER AND ORDERING INFO FOR A REPLACEMENT SET OF PADDLES. THE REMOVED PADDLE SET HAS BEEN RETURNED TO PHYSIO-CONTROL FOR FURTHER EVAL. PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE ROOT CAUSE OF THE REPORTED FAILURE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE'S SHOCK BUTTON WILL NOT DELIVER ENERGY. THERE WAS NO PT 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 |