BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUTPLUS FINAL ASSY, REV-RIGHT

    MDR report key: 1915309 · Received November 2, 2010

    Report

    Report Number
    1518293-2010-00145
    Event Type
    Malfunction
    Date Received
    November 2, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER DID NOT REQUEST COVIDIEN SERVICE ENGINEER SITE VISIT. CUSTOMER TROUBLESHOOT SYSTEM WITH COVIDIEN TECH SUPPORT VIA PHONE. COVIDIEN TECH SUPPORT ADVISED CUSTOMER THE TRANSDUCER AMP PCB'S AS THE COMMON FACTOR TO ALL MOVEMENTS WAS 24V. TECH SUPPORT ASSISTED CUSTOMER IN TROUBLESHOOTING THE PROBLEM TO THE 24V DC POWER SUPPLY. CHECK ON THE OUTPUT OF THE 24V DC POWER SUPPLY FOUND NO OUTPUT TO BE MEASURED. CUSTOMER REPLACED THE POWER SUPPLY AND REPORTS THE POWER SUPPLY REPLACEMENT HAS RESOLVED THE ISSUE. SYSTEM IS FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    TABLE WILL NOT MOVE IN ANY DIRECTION. TUBE AND IMAGE INTENSIFIER ARE MISALIGNED AND PARK ARM IS RETRACTED. EVERY TABLE MOTION YIELDS A HARDWARE ERROR, POSSIBLE COLLISION ALERT WITH THE CODE OF THE FUNCTION BEING PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUTPLUS FINAL ASSY, REV-RIGHT UROLOGY SUITE KQS LIEBEL-FLARSHEIM CO. HUTPLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK