FDA Adverse Event
Malfunction
Summary report: N
1600 SEM AUTOMATIC DEFIBRILLATOR
MDR report key: 504470
·
Received December 12, 2003
Report
- Report Number
- 1220908-2003-01941
- Event Type
- Malfunction
- Date Received
- December 12, 2003
- Date of Event
- November 21, 2003
- Report Date
- November 21, 2003
- Manufacturer
- ZOLL MEDICAL CORP.
- Product Code
- MKJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SD, US
- Reporter Occupation
- NOT APPLICABLE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1600 SEM AUTOMATIC DEFIBRILLATOR | DEFIBRILLATOR | MKJ | ZOLL MEDICAL CORP. | 1600 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Other |