FDA Adverse Event
Malfunction
Summary report: N
ASSY, CONSOLE, BVI9600
MDR report key: 3030854
·
Received March 28, 2013
Report
- Report Number
- 3022472-2013-00072
- Event Type
- Malfunction
- Date Received
- March 28, 2013
- Date of Event
- February 27, 2013
- Report Date
- February 27, 2013
- Manufacturer
- VERATHON MEDICAL
- Product Code
- CCW
- PMA / PMN Number
- K082456
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER HAS REQUESTED ADD'L TRAINING ON THE DEVICE TO DETERMINE IF THEY ARE EXPERIENCING A TECHNIQUE ISSUE OR IF THE DEVICE HAS MALFUNCTIONED AND NEEDS TO BE RETURNED. FOLLOW-UP RESULTS ON TRAINING ARE PENDING.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE DISPLAYED AN INACCURATE AORTA READING DURING USE ON A PT. THIS WAS A LOANER DEVICE. THE CUSTOMER IS NOT SURE IF THE REPORTED ISSUE IS A RESULT OF THE DEVICE MALFUNCTIONING OR IF THEY WERE NOT USING THE PROPER TECHNIQUE TO CAPTURE THE READING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 127504 | ASSY, CONSOLE, BVI9600 | NONE | CCW | VERATHON MEDICAL | 0570-0212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | BLADDERSCAN BVI 9400/9600: MODEL # 0570-0188,| SERIAL # (B)(4), MFG DATE 10/2010| PROBE| ASSY |