FDA Adverse Event
Injury
Summary report: N
PHYSIO-CONTROL
MDR report key: 1013916
·
Received March 13, 2008
Report
- Report Number
- MW5005877
- Event Type
- Injury
- Date Received
- March 13, 2008
- Date of Event
- March 12, 2008
- Report Date
- March 13, 2008
- Manufacturer
- MEDTRONIC - PHYSIO CONTROL
- Product Code
- LDD
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
FAILURE OF AUTOMATIC EXTERNAL DEFIBRILLATOR TO DELIVER ELECTRICAL THERAPY TO A POTENTIALLY LETHAL CARDIAC ARRHYTHMIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHYSIO-CONTROL | LIFEPAK 500 | LDD | MEDTRONIC - PHYSIO CONTROL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Disability |