FDA Adverse Event
Malfunction
Summary report: N
BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR
MDR report key: 779146
·
Received August 30, 2006
Report
- Report Number
- 3015876-2006-00232
- Event Type
- Malfunction
- Date Received
- August 30, 2006
- Report Date
- July 31, 2006
- Manufacturer
- MEDTRONIC EMERGENCY RESPONSE SYSTEMS
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
OUT-OF-BOX FAILURE (OBF). ACCORDING TO THE REPORTER, WHEN THE DEVICE WAS FIRST POWERED ON, THE VOICE PROMPTS WERE INAUDIBLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPHASIC LIFEPAK 500 AUTOMATED EXTERNAL DEFIBRILLATOR | EXTERNAL DC DEFIBRILLATOR / CARDIAC MONITOR | MKJ | MEDTRONIC EMERGENCY RESPONSE SYSTEMS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |