BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUTPLUS FINAL ASSY, REV-RIGHT

    MDR report key: 1081055 · Received July 21, 2008

    Report

    Report Number
    1518293-2008-00224
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    June 23, 2008
    Report Date
    June 23, 2008
    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

    FIELD SERVICE ENGINEER (FSE) TROUBLESHOT SYSTEM TO A FAILED IMAGE INTENSIFIER LOW VOLTAGE POWER SUPPLY WHICH WAS REPLACED. FURTHER TROUBLESHOOTING REVEALED A BAD HIGH VOLTAGE POWER SUPPLY WHICH MAY HAVE BEEN DAMAGED WHEN THE II LOW VOLTAGE POWER SUPPLY WENT OUT. FSE REPLACED HIGH VOLTAGE POWER SUPPLY. THEN, UNRELATED TO THE NON FLUORO ISSUE, THE FSE ALSO REPAIRED THE POWER CABLE, ADJUSTED VIDEO, AND ALIGNED COLLIMATOR. ON COMPLETION, THE SYSTEM TESTED GOOD IN ACCORDANCE WITH SYSTEM SERVICE MANUAL AND WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A MALE WAS UNDER GOING AN IMPLANTATION OF A DIALYSIS CATHETER, WHEN THE PHYSICIAN STEPPED ON THE FLUORO PEDAL, IT DID NOT COME ON. HE REPORTED THAT A PORTABLE C-ARM/TABLE WAS BROUGHT INTO THE PROCEDURE ROOM AND THE PT WAS TRANSFERRED ON TO IT WITHOUT ANY COMPLICATIONS AND THE PROCEDURE WAS COMPLETED.

    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 70 YR