FDA Adverse Event
Malfunction
Summary report: N
BLADDERSCAN
MDR report key: 1645764
·
Received March 11, 2010
Report
- Report Number
- 1645764
- Event Type
- Malfunction
- Date Received
- March 11, 2010
- Date of Event
- March 2, 2010
- Report Date
- March 11, 2010
- Manufacturer
- VERATHON
- Product Code
- EXQ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
THE NURSE WAS USING THE SYSTEM ON A PATIENT WHEN IT LOCKED UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BLADDERSCAN | BLADDER SCANNER | EXQ | VERATHON | BVI9400 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |