FDA Adverse Event
Malfunction
Summary report: N
HP ECHOTRANSDUCER
MDR report key: 107692
·
Received July 1, 1997
Report
- Report Number
- 107692
- Event Type
- Malfunction
- Date Received
- July 1, 1997
- Date of Event
- March 11, 1997
- Report Date
- March 21, 1997
- Manufacturer
- HEWLETT PACKARD
- Product Code
- DXK
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
OUTPATIENT WAS TO UNDERGO ECHOCARDIOGRAM. AS TRANSDUCER TOUCHED PT'S CHEST, SHE INDICATED THAT SHE FELT A SHOCK, LASTING ONLY A FEW SECONDS. NO BURN WAS EVIDENT. MACHINE WAS TAKEN OUT OF SERVICE. TRANSDUCER FOUND TO HAVE A NICK/SMALL CRACK DOWN THE MIDDLE OF THE HEAD. HEAD REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HP ECHOTRANSDUCER | ECHOTRANSDUCER | DXK | HEWLETT PACKARD | 1000 | NONE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |