BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUTIV TABLE ASSY REV W/COLOR

    MDR report key: 1371318 · Received February 9, 2009

    Report

    Report Number
    1518293-2009-00009
    Event Type
    Malfunction
    Date Received
    February 9, 2009
    Date of Event
    January 9, 2009
    Report Date
    January 12, 2009
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SERVICE ENGINEER TROUBLESHOT THE TABLE, WHICH WASN'T MOVING UPON ARRIVAL, BUT BEGAN TO WORK SOON AFTER, WITHOUT FSE ADJUSTING OR CORRECTING ANYTHING. FSE TROUBLESHOT TO THE 5 VOLT POWER SUPPLY, WHICH WAS READING LOW AT 5.03 V, AND ADJUSTED THIS TO 5.10 VOLTS. FSE TESTED AND VERIFIED PROPER OPERATION PER HUT SERVICE MANUAL 400955. UNIT RETURNED TO FULL SERVICE BY THE CUSTOMER.

    Description of Event or Problem · 1

    IN 2009, CUSTOMER REPORTS THAT AT THE START OF DAY, THE TABLE WILL POWER-UP, BUT NOT PERFORM BASIC FUNCTIONS. REPORTED INTERMITTENT PROBLEMS WITH NO TABLE MOVEMENT RECENTLY AS WELL. DO NOT HAVE A BACK-UP ROOM THAT WILL WORK FOR USE FOR ALL SCHEDULED PROCEDURES. NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUTIV TABLE ASSY REV W/COLOR UROLOGY SUITES KQS LIEBEL-FLARSHEIM CO. HUT IV NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK