BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 2182234 · Received July 12, 2011

    Report

    Report Number
    1518293-2011-00118
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIEBEL FLARSHEIM TECH SUPPORT ADVISED CUSTOMER OF A CONSOLE REPLACEMENT SINCE THEY HAVE A DAP SYSTEM WITH COLLIMATOR-MOUNTED-DISPLAYS. TECH SUPPORT CALLED FOR FOLLOW UP AND CUSTOMER STATED WE WILL HAVE TO CALL BACK LATER. AFTER REPEATED ATTEMPTS, WITHOUT SUCCESS TO CONTACT CUSTOMER FOR FOLLOW UP, TECH SUPPORT CLOSED THE SERVICE TICKET. THIS UNIT IS SUPPORTED BY (B)(4). QA WILL CONTINUE TO MONITOR/TREND FOR SIMILAR ISSUES AND IDENTIFY SIGNIFICANT QUALITY TRENDS TO INPUT FOR CORRECTIVE ACTION.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS AFTER A POWER OUTAGE, THE GENERATOR CONSOLE WILL NOT FUNCTION. CUSTOMER DOES NOT HAVE A BACK UP ROOM AND PHYSICIAN'S ARE HAVING TO CANCEL PATIENT PROCEDURES. NO REPORTED INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA