FDA Adverse Event
Injury
Summary report: N
LAERDAL HEARTSTART 3000
MDR report key: 287211
·
Received July 21, 2000
Report
- Report Number
- MW1019362
- Event Type
- Injury
- Date Received
- July 21, 2000
- Date of Event
- July 19, 2000
- Report Date
- July 21, 2000
- Manufacturer
- LAERDAL MEDICAL CORP
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
LAERDAL HEARTSTART 3000 AUTOMATIC EXTERNAL DEFIBRILLATOR FAILED TO RECOGNIZE VENTRICULAR FIBRILLATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAERDAL HEARTSTART 3000 | AED | MKJ | LAERDAL MEDICAL CORP | HEARTSTART 3000QR | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Life Threatening |