BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 1030286 · Received April 15, 2008

    Report

    Report Number
    1518293-2008-00167
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 18, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM FIELD SERVICE ENGINEER SERVICE REPORT LF FSE TROUBLE SHOT AND FOUND GIM COMMUNICATION MESSAGE VIA PLATINUM ONE DISPLAY. CHECKED CONNECTIONS BETWEEN THE GIM BOX AND POWER CABLE, WHICH WAS FOUND DISCONNECTED. RESEATED CONNECTION AND FLUORO IS NOW ACTIVE. TESTED REMAINING FUNCTIONS OF UNIT. INVESTIGATION COMPLETED AND SYSTEMS RETURNED TO FULL SERVICE BY CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT BEFORE PLACING THE PT ONTO THE PROCEDURE TABLE, THAT THE OR STAFF CHECKED THE OPERATION OF THE EQUIPMENT AND FOUND OUT THAT THE FLUORO WAS NOT OPERATIONAL. HE REPORTED THAT THE PT WAS TRANSFERRED TO ANOTHER PROCEDURE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUT EXT DR FINAL ASSY-STANDARD UROLOGY TABLE KQS LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA