BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY, CONSOLE, BLADDERSCAN BVI 9400

    MDR report key: 2972457 · Received February 15, 2013

    Report

    Report Number
    3022472-2013-00064
    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
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER CARE EXPLAINED TO THE CUSTOMER THAT THEY SHOULD NOT CART THE INSTRUMENT AROUND WHILE IT IS ON, AS THE BATTERY CAN GET JOSTLED AND CAUSE IT TO FREEZE DURING USE. CUSTOMER CARE ALSO EXPLAINED THAT IF THE END-USER IS PRESSING THE SCAN BUTTON VERY QUICKLY MULTIPLE TIMES, IT CAN FREEZE UP. THEY NEED TO ALLOW TIME FOR THE UNIT TO REACT TO EACH BUTTON PRESS. THE CUSTOMER STATED THAT HE WOULD CHECK WITH THE END-USERS AND CALL BACK IF NEEDED.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE DEVICE WAS LOCKING UP AFTER NOT GOING INTO SLEEP MODE AND SITTING FOR APPROX. 30 MINUTES. THE CUSTOMER CALLED BACK TO STATE THAT THE DEVICE DID GO INTO SLEEP MODE, BUT IT LOCKED UP WHILE SCANNING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69524 ASSY, CONSOLE, BLADDERSCAN BVI 9400 NONE IYO VERATHON INCORPORATED 0570-0190

    Patients

    Seq Age Sex Outcome Treatment
    1