FDA Adverse Event
Malfunction
Summary report: N
LIFEPAK 20 DEFIBRILLATOR/MONITOR
MDR report key: 776058
·
Received August 30, 2006
Report
- Report Number
- 3015876-2006-00235
- Event Type
- Malfunction
- Date Received
- August 30, 2006
- Report Date
- August 2, 2006
- Manufacturer
- MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC.
- Product Code
- LDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
OUT-OF-BOX FAILURE (OBF). WHILE TRAINING HOSP PERSONNEL FOR USE OF THE DEVICE IN AED MODE AND WITH THE DEVICE CONNECTED TO A PT SIMULATOR, THE REPORTER STATED THE DEVICE GAVE A CONTINUOUS "MOTION" ALARM WHEN THE ANALYZE BUTTON WAS PRESSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEPAK 20 DEFIBRILLATOR/MONITOR | EXTERNAL DC DEFIBRILLATOR/CARDIAC | LDD | MEDTRONIC EMERGENCY RESPONSE SYSTEMS, INC. | 20 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |