FDA Adverse Event
Malfunction
Summary report: N
BVI 3000
MDR report key: 5842069
·
Received August 2, 2016
Report
- Report Number
- 3022472-2016-00035
- Event Type
- Malfunction
- Date Received
- August 2, 2016
- Date of Event
- June 30, 2016
- Report Date
- July 7, 2016
- Manufacturer
- VERATHON MEDICAL
- Product Code
- ITX
- PMA / PMN Number
- K082456
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS PRODUCT HAS NOT BEEN RECEIVED FOR EVALUATION, THEREFORE THE PROBLEM CANNOT BE CONFIRMED.
Description of Event or Problem · 1
THE PATIENT WAS UNABLE TO VOID SO MADE AN URGENT APPOINTMENT. THE CUSTOMER, USING A BVI 3000 CONTROL BOX, SENT THE PATIENT HOME BASED ON THE MACHINE'S READING 0ML. LATER THAT EVENING THE PATIENT HAD TO GO TO THE ER BECAUSE HE WENT INTO RETENTION. NO DELAY IN THE PROCEDURE OR USE OF A BACK-UP DEVICE WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 492367 | BVI 3000 | TRANSDUCER, ULTRASONIC, DIAGNOSTIC | ITX | VERATHON MEDICAL | 0570-0090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |