BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 2142058 · Received May 24, 2011

    Report

    Report Number
    1518293-2011-00090
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 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

    TECH SUPPORT HELPED CUSTOMER TROUBLESHOOT BY HAVING CUSTOMER CHECK FOR ANY ERROR MESSAGES. THERE WERE NO ERROR MESSAGES AND ALL SYSTEMS WERE ON. TECH SUPPORT HAD BIOMED CHECK IF THE FOOTSWITCH WAS WORKING PROPERLY BY CHECKING CONTROL SIGNALS FROM THE X-RAY INTERFACE PCB, AND ADVISED BIOMED THAT IF NO ACTIVE SIGNALS WERE PRESENT, THEY WOULD NEED TO REPLACE THE FOOTSWITCH. ON (B)(6) 2011: PRODUCT MONITORING F/U; CUSTOMER REPORTED THEY FOUND THE PROBLEM TO BE A FOOTSWITCH CABLE CONNECTION, WHICH BIOMED RE-TERMINATED AND NOW ALL IS FUNCTIONING WELL. SYSTEM RETURNED TO FULL SERVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2011: CUSTOMER REPORTED THAT A PT WAS UNDERGOING AN UNK UROLOGY PROCEDURE WHEN THE FLUORO FAILED. CUSTOMER REPORTS THE PROCEDURE WAS COMPLETED USING RAD IMAGING. CUSTOMER DID NOT PROVIDE PATIENT OR PROCEDURAL INFO OTHER THAN TO SAY, PROCEDURE WAS COMPLETED, NO 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 UNK