BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY, CONSOLE, BLADDERSCAN BVI 9400

    MDR report key: 2972525 · Received February 15, 2013

    Report

    Report Number
    3022472-2013-00043
    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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE WAS CONFIRMED. THE SYSTEM DID NOT POWER UP BECAUSE THE CUSTOMER'S BATTERIES WERE NOT CHARGED. WHILE CHARGING THE CUSTOMER'S BATTERIES, THE TECH USED THE CUSTOMER'S ENTIRE CHARGING SYSTEM AND NOTICED THAT THE POWER SUPPLY WAS EXTREMELY HOT, MORE THAN IT SHOULD BE. THE CUSTOMER'S ENTIRE CHARGING SYSTEM WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE DID NOT TURN ON. A SOFT RESET OCCURRED WITH TWO DIFFERENT BATTERIES AND THE SYSTEM STILL DID NOT WORK. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69389 ASSY, CONSOLE, BLADDERSCAN BVI 9400 NONE IYO VERATHON MEDICAL 0570-0190

    Patients

    Seq Age Sex Outcome Treatment
    1