FDA Adverse Event
Death
Summary report: N
LIFEPAK 300 AUTOMATIC ADVISORY DEFIBRILLATOR
MDR report key: 956374
·
Received November 30, 2007
Report
- Report Number
- 3015876-2007-00543
- Event Type
- Death
- Date Received
- November 30, 2007
- Date of Event
- November 6, 2007
- Report Date
- November 6, 2007
- Manufacturer
- PHYSIO-CONTROL, INC.
- Product Code
- MKJ
- PMA / PMN Number
- K925936
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
PHYSIO-CONTROL, INC. EVALUATED THE DEVICE. THE ROOT CAUSE WAS DETERMINED TO BE DUE TO A FAILURE OF THE MAIN PCB ASSEMBLY. AFTER REPLACING THE MAIN PCB ASSEMBLY, PROPER OPERATION WAS CONFIRMED, AND THE DEVICE WAS RETURNED TO THE CUSTOMER.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD A SERVICE WRENCH PRESENT, AND WOULD NOT CHARGE TO DEFIBRILLATE A PT THAT WAS ANALYZED TO HAVE A SHOCKABLE RHYTHM. NO OTHER DEVICE AVAILABLE TO DEFIBRILLATE PT. THE PT WAS TRANSPORTED TO THE HOSP AND RESUSCITATION WAS ATTEMPTED. THE PT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 300 AUTOMATIC ADVISORY DEFIBRILLATOR | MKJ | PHYSIO-CONTROL, INC. | 300 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Death |