FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK CR PLUS DEFIBRILLATOR
MDR report key: 1021918
·
Received March 28, 2008
Report
- Report Number
- 3015876-2008-00240
- Event Type
- Malfunction
- Date Received
- March 28, 2008
- Date of Event
- February 27, 2008
- Report Date
- February 27, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K011144
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, 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 IS DISPLAYING A LOW CHARGE-PAK INDICATOR AND A LOW INTERNAL BATTERY INDICATOR. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED 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 |