BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLADDERSCAN

    MDR report key: 493914 · Received October 23, 2003

    Report

    Report Number
    MW1029951
    Event Type
    Injury
    Date Received
    October 23, 2003
    Date of Event
    October 16, 2003
    Report Date
    October 23, 2003
    Manufacturer
    DIAGNOSTIC ULTRASOUND INC.
    Product Code
    ITX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AT 6:15AM THE FIRE/SAFETY SPECIALIST RESPONDED TO WARD AND CHECKED A DIAGNOSTIC ULTRASOUND MODEL 2500 BLADDERSCAN UNIT THAT HAD CAUSED AN EMPLOYEE TO RECEIVE AN ELECTRICAL SHOCK. THE EMPLOYEE HAD BEEN TAKEN TO THE ER FOR TREATMENT. AT 6:20AM THE FIRE/SAFETY SPECIALIST FOUND THE PIECE OF EQUIPMENT IN QUESTION IN THE CORRIDOR OUTSIDE OF THE NURSES STATION. THERE WERE SIGNS OF PHYSICAL DAMAGE TO THE POWER TRANSFORMER FOR THIS BLADDER-SCAN UNIT. THE UNIT WAS IMMEDIATELY REMOVED FROM SERVICE AND TAKEN TO BIO-MEDICAL ENGINEERING FOR INVESTIGATION. BIOMEDICAL ENGINEERING FOUND THAT THE POWER TRANSFORMER -BATTERY CHARGER- HAD FAILED. THE 120V POWER PLUG SOCKET IN THE POWER TRANSFORMER HAD COME LOOSE AND SHORTED THE UNIT TO GROUND ON THE PRINTED CIRCUIT BOARD. THE POWER TRANSFORMER IS AN AULT INC. SWITCHING POWER SUPPLY, MODEL U102DKA0700F61.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLADDERSCAN DIAGNOSTIC ULTRASOUND SCANNER ITX DIAGNOSTIC ULTRASOUND INC. 2500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization MODEL U102DKA0700F61.| AULT INC. SWITCHING POWER SUPPLY,