BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY, PROBE, BLADDERSCAN BVI 9400/9600

    MDR report key: 2972612 · Received February 15, 2013

    Report

    Report Number
    3022472-2013-00019
    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
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REPRESENTATIVE REPLACED THE FAULTY DCM. HE ALSO FOUND THE PROBE'S PCBA J7 PIN WAS DAMAGED AND REPLACED THE PROBE PCBA. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DISPLAYED LOW READINGS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69428 ASSY, PROBE, BLADDERSCAN BVI 9400/9600 NONE IYO VERATHON MEDICAL 0570-0188

    Patients

    Seq Age Sex Outcome Treatment
    1