FDA Adverse Event
Death
Summary report: N
LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES
MDR report key: 1020390
·
Received March 27, 2008
Report
- Report Number
- 3015876-2008-00233
- Event Type
- Death
- Date Received
- March 27, 2008
- Date of Event
- February 26, 2008
- Report Date
- February 29, 2008
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K991910
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL CONTINUES TO INVESTIGATE THE REPORTED EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE FIRE DEPT ATTEMPTED TO DEFIBRILLATE 3 TIMES AS 200/300/360, AND THE DEVICE WOULD NOT DELIVER ENERGY. THE PT WAS NOT RESUSCITATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES | MKJ | PHYSIO-CONTROL, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Death |