BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY - STANDARD

    MDR report key: 4102327 · Received August 27, 2014

    Report

    Report Number
    1518293-2014-00100
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    July 30, 2014
    Report Date
    July 30, 2014
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER (FSE) INVESTIGATED AND CONFIRMED THE TABLE MOTIONS COMPLAINT, TROUBLESHOT AND REPLACED THE 24V POWER SUPPLY. AFTER REPLACING THE POWER SUPPLY, FSE FOUND THAT ONLY HALF OF TABLE MOTIONS WERE OPERABLE. FURTHER TROUBLESHOOTING SHOWED FAILURE OF THE HYDRAULIC PUMP MOTOR CONTROLLER. FSE REPLACED THE HYDRAULIC PUMP MOTOR CONTROL ASSEMBLY AND THE TABLE OPERATED NORMALLY. THE UNIT WAS CHECKED FOR PROPER OPERATION PER SERVICE MANUAL AND RETURNED TO FULL SERVICE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS VIA PHONE THAT DURING AN KIDNEY STONE REMOVAL PROCEDURE, PATIENT GENDER AND AGE NOT REPORTED BY THE CUSTOMER, THE TABLE MOVEMENTS FAILED. STAFF MOVED THE PATIENT TO ANOTHER ROOM, BUT THEY MOVED THE PATIENT BACK TO THE UROLOGY ROOM, AND USED THE TABLE "OVER-RIDE" BUTTON TO COMPLETE THE PROCEDURE. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522663 HUT EXT DR FINAL ASSY - STANDARD IXR LIEBEL FLARSHEIM DR FINAL A HUT EXT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK