FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 9 DEFIBRILLATOR/MONITOR
MDR report key: 1070770
·
Received July 3, 2008
Report
- Report Number
- 3015876-2008-00749
- Event Type
- Malfunction
- Date Received
- July 3, 2008
- Date of Event
- June 4, 2008
- Report Date
- June 4, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- LDD
- PMA / PMN Number
- K881153
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL SUPPLIED TROUBLESHOOTING ASSISTANCE AND PARTS INFO TO CUSTOMER FOR REPAIR.
Description of Event or Problem · 1
FOUND DURING TESTING. ACCORDING TO THE REPORTER, WHEN HE CHARGES THE DEVICE TO 360JOULES, IT WILL NOT CHARGE PAST 85JOULES. THERE WAS NO PATIENT ASSOCIATED WITH THE REPORT.
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 |