FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK CR PLUS DEFIBRILLATOR
MDR report key: 1172019
·
Received September 18, 2008
Report
- Report Number
- 3015876-2008-01220
- Event Type
- Malfunction
- Date Received
- September 18, 2008
- Date of Event
- February 22, 2008
- Report Date
- February 22, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K011144
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED FAILURE.
Description of Event or Problem · 1
PHYSIO-CONTROL IS CURRENTLY INVESTIGATING UNITS THAT HAVE EXHIBITED COMPLAINTS OF DEPLETED INTERNAL BATTERY CAPACITY. THE DOWNLOADS INDICATE DEVICES MALFUNCTIONED DURING 3:00 A.M. SELF TEST, WHICH ALLOWED DEVICE TO STAY POWERED ON CAUSING BATTERY DEPLETION. INITIAL DATA REVIEW INDICATES THIS IS A RECENT (WITHIN LAST 2 YEARS) PHENOMENA.
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 |