BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY, PROBE, BLADDERSCAN BVI 9400/9600

    MDR report key: 2961276 · Received February 8, 2013

    Report

    Report Number
    3022472-2013-00012
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    VERATHON MEDICAL
    Product Code
    ITX
    PMA / PMN Number
    K071217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS CONFIRMED. THE DEVICE READINGS SHOWED 0ML. A FAULTY SCAN CABLE WAS REPLACED. ALSO REPLACED WERE A FAULTY PROBE DCM, SINCE THERE WAS LEAKING OIL FROM AN UNK SOURCE. THE SERVICE REP ALSO REPLACED THE BOTTOM AND DAMAGED TOP PROBE COVER. THE PROBE PCBA PASSED VISUAL INSPECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE READ 0ML WHEN 300 ML WAS ACTUALLY IN THE BLADDERS. THE READINGS WERE 300-400 CC'S OFF. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53979 ASSY, PROBE, BLADDERSCAN BVI 9400/9600 NONE ITX VERATHON MEDICAL 0570-0188

    Patients

    Seq Age Sex Outcome Treatment
    1