FDA Adverse Event
Injury
Summary report: N
SYNCHRONOUS DEFIBRILLATOR
MDR report key: 10815
·
Received December 13, 1993
Report
- Report Number
- 10815
- Event Type
- Injury
- Date Received
- December 13, 1993
- Date of Event
- November 16, 1993
- Report Date
- November 24, 1993
- Manufacturer
- MENNEN MEDICAL, INC.
- Product Code
- LDD
- Report Source
- User Facility report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
DEFIBRILLATOR TURNED ON, CHARGED TO 360J. NURSE PLACED PADDLES ON PT. DEFIBRILLATOR DID NOT DISCHARGE THREE TRIES. ON FOURTH TRY, DEFIBRILLATOR DISCHARGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRONOUS DEFIBRILLATOR | SYNCHRONOUS DEFIBRILLATOR | LDD | MENNEN MEDICAL, INC. | 604-090, 604/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Life Threatening |