BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY, PROBE, BLADDERSCAN BVI 9400/9600

    MDR report key: 2972515 · Received February 15, 2013

    Report

    Report Number
    3022472-2013-00034
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    VERATHON MEDICAL
    Product Code
    IYO
    PMA / PMN Number
    K071217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND REPLACED WITH A BVI 3000 SYS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE SOMETIMES DID NOT BOOT UP. WHEN IT DOES THE PROBE WORKS SPORADICALLY. THE CUSTOMER WAS ABLE TO GET ONE SCAN ON THE PHANTOM AND THEN IT WOULD NOT WORK AFTER THAT ONE SCAN. IT APPEARED THAT THE TRIGGER WAS JAMMED AND WOULD NOT TAKE ANY OTHER READINGS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69473 ASSY, PROBE, BLADDERSCAN BVI 9400/9600 NONE IYO VERATHON MEDICAL 0570-0188

    Patients

    Seq Age Sex Outcome Treatment
    1