FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK CR PLUS DEFIBRILLATOR
MDR report key: 1171558
·
Received September 17, 2008
Report
- Report Number
- 3015876-2008-01170
- Event Type
- Malfunction
- Date Received
- September 17, 2008
- Date of Event
- August 20, 2008
- Report Date
- August 20, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K011144
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
A REPLACEMENT DEVICE WAS PROVIDED TO THE CUSTOMER. PHYSIO-CONTROL WILL SUBMIT A SUPPLEMENTAL REPORT ON THIS EVENT TO THE FDA AS PROVIDED.
Description of Event or Problem · 1
ACCORDING TO THE REPORTER, WHILE INSPECTING THE FACILITY'S AED DEVICES, THE REPORTER OBSERVED THAT ONE OF THEIR DISPLAYS THE CHARGE-PAK, ATTENTION, AND SERVICE WRENCH ICONS AND WILL NOT POWER ON.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK CR PLUS DEFIBRILLATOR | MKJ | PHYSIO-CONTROL, INC. | CRPLUS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |