BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2102222 · Received May 17, 2011

    Report

    Report Number
    1518293-2011-00093
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    KQS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECH SUPPORT TROUBLESHOT WITH FACILITY BIOMED GIVING HIM ADVISE ON WHAT TO CHECK. ON (B)(4) 2011; TECH SUPPORT FOLLOWED UP WITH FACILITY BIOMED WHO REPORTS THAT AFTER RECYCLING GENERATOR, THE SYSTEM HAS BEEN FULLY FUNCTIONAL, NO MORE ISSUES. BIOMED DOES NOT WANT A FIELD SERVICE ENGINEER TO VISIT ON UNIT, WORKING WELL. QUALITY ASSURANCE WILL CONTINUE TO MONITOR AND TREND FOR SIMILAR ISSUES AND IDENTIFY SIGNIFICANT QUALITY TRENDS TO INPUT FOR CORRECTIVE ACTION.

    Description of Event or Problem · 1

    ON (B)(6) 2011: CUSTOMER REPORTS THAT PHYSICIAN WAS PERFORMING AN UNDETERMINED UROLOGY PROCEDURE ON A PT WHEN THE FLUORO FAILED. STAFF MOVED THE PT TO ANOTHER ROOM, WHERE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. CUSTOMER DID NOT PROVIDE INFO ON PT OR PROCEDURE OTHER THAN TO SAY THE PROCEDURE WAS COMPLETED, NO REPORTED INJURY.

    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