BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY, PROBE, BLADDERSCAN BVM 9500

    MDR report key: 2961251 · Received February 8, 2013

    Report

    Report Number
    3022472-2013-00009
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    VERATHON MEDICAL
    Product Code
    IYO
    PMA / PMN Number
    K090214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS CONFIRMED BY TESTING THE PROBE WITH A NEW DCM, BUT THE RESULTS WERE STILL THE SAME. THE SCAN CABLE WAS REPLACED. TROUBLESHOOTING ALSO RESULTED IN ADD'L REPAIRS OF THE PROBE. IT WAS DISCOVERED THAT THE PLASTIC TABS THAT CONNECT THE PROBE BOTTOM TO THE PROBE TOP WERE DAMAGED. ALSO, THE J7 CONTACT ON THE PROBE PCBA WAS DETACHED. THE DCM, PROBE PCBA, AND PROBE BOTTOM WERE REPLACED. THE SYSTEM NOW OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE READ 0ML FOR ALL READINGS. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55210 ASSY, PROBE, BLADDERSCAN BVM 9500 NONE IYO VERATHON MEDICAL 0570-0208

    Patients

    Seq Age Sex Outcome Treatment
    1