BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 1379674 · Received March 3, 2009

    Report

    Report Number
    1518293-2009-00046
    Event Type
    Malfunction
    Date Received
    March 3, 2009
    Date of Event
    February 13, 2009
    Report Date
    February 13, 2009
    Manufacturer
    LIEBEL FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECHNICAL SUPPORT ADVISED BIOMED TECH TO USE SERVICE APPLICATION WITH PASSWORD. THIS BROUGHT THE UNIT UP TO CLINICAL APPLICATION MODE. SYSTEM IS WORKING PROPERLY PER CUSTOMER. TECHNICAL SUPPORT CALLED BACK TO FOLLOW UP WITH BIOMED. UNIT CONTINUES TO OPERATE WITHOUT PROBLEMS.

    Description of Event or Problem · 1

    ON 2/16: CUSTOMER REPORTS THE SUITE DID NOT HAVE FLUORO CAPABILITY. NO INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK