BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY, PROBE, BLADDERSCAN BVI 9400/9600

    MDR report key: 2972518 · Received February 15, 2013

    Report

    Report Number
    3022472-2013-00038
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    VERATHON INCORPORATED
    Product Code
    IYO
    PMA / PMN Number
    K071217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FAILURE WAS NOT CONFIRMED. THE SERVICE REP REPLACED THE BOTTOM AND CRACKED TOP PROBE COVER, A FAULTY DCM, AND A CRACKED BASE HANDLE TOP. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE READ LL ZEROS ON MULTIPLE PATIENTS AND BY MULTIPLE USERS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69474 ASSY, PROBE, BLADDERSCAN BVI 9400/9600 NONE IYO VERATHON INCORPORATED 0570-0188

    Patients

    Seq Age Sex Outcome Treatment
    1