FDA Adverse Event
Summary report: N
SONARA
MDR report key: 1982166
·
Received February 3, 2011
Report
- Report Number
- 1982166
- Date Received
- February 3, 2011
- Report Date
- February 3, 2011
- Manufacturer
- CAREFUSION
- Product Code
- IYN
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
NEW TCD (TRANSCRANIAL DOPPLER) EQUIPMENT PURCHASED. WHILE A FACILITY STAFF MEMBER WAS PRACTICING WITH THE EQUIPMENT, SHE TOUCHED THE DEVICE TO HER NECK (WHICH IS A LOCATION THAT THE DEVICE WOULD BE APPLIED TO THE PATIENT) AND EXPERIENCED AN "ELECTRICAL SHOCK." TCD DEVICE WAS REMOVED FROM USE AND THE COMPANY CONTACTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SONARA | ULTRASOUND, DOPPLER, TRANSCRANIAL | IYN | CAREFUSION | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |