FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 9 DEFIBRILLATOR/MONITOR
MDR report key: 1060520
·
Received June 11, 2008
Report
- Report Number
- 3015876-2008-00593
- Event Type
- Malfunction
- Date Received
- June 11, 2008
- Date of Event
- May 15, 2008
- Report Date
- May 15, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K881153
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE BIOMED SWAPPED OUT THE DEVICE'S PADDLES SET WITH KNOWN GOOD PADDLES AND OBSERVED PROPER OPERATION. THE BIOMED EVALUATED THE SWAPPED OUT STANDARD PADDLES ASSEMBLY AND OBSERVED A LOOSE CONNECTION INSIDE. PHYSIO-CONTROL SUPPLIED THE BIOMED WITH PARTS INFORMATION FOR REPAIR/REPLACEMENT.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, THE DEVICE'S ENERGY SELECT LEVEL WON'T GO ABOVE 50 JOULES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 9 DEFIBRILLATOR/MONITOR | LDD | PHYSIO-CONTROL, INC. | 9 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |