BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUTIV TABLE ASSY REV W/COLOR

    MDR report key: 1051258 · Received May 22, 2008

    Report

    Report Number
    1518293-2008-00184
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 28, 2008
    Report Date
    April 28, 2008
    Manufacturer
    LIEBEL-FLARSHEIM CO
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM MANUFACTURING REPORT. FIELD SERVICE ENGINEER DISCUSSED PROBLEM WITH CUSTOMER BIOMED AND POSSIBLE SOLUTIONS. BIOMED DECIDED TO PURCHASE FROM A THIRD PARTY AND INSTALL HIMSELF. L F QA REPORTS, PER THE CUSTOMER BIOMED, "THE PROBLEM WAS AN INAPPROPRATE "FLUORO INTERLOCK" CONDITION, I SUSPECT CAUSED BY A HAD RELAY ON THAT BOARD. WE REPLACED THE X-RAY INTERFACE BOARD." UNIT RETURNED TO FULL SERVICE, NO FURTHER ISSUE REPORTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THAT FLUORO DROPPED OUT DURING AN UNK TYPE OF PROCEDURE. PT WAS MOVED TO ANOTHER ROOM AND PROCEDURE COMPLETED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK