FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK CR PLUS DEFIBRILLATOR
MDR report key: 1170323
·
Received September 12, 2008
Report
- Report Number
- 3015876-2008-01104
- Event Type
- Malfunction
- Date Received
- September 12, 2008
- Date of Event
- August 14, 2008
- Report Date
- August 14, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K0111144
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WOULD NOT POWER ON. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THIS EVENT.
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 |