BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 3102441 · Received May 1, 2013

    Report

    Report Number
    1518293-2013-00096
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 19, 2013
    Report Date
    May 1, 2013
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IXR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TECH SUPPORT TROUBLESHOOT SYSTEM WITH BIOMED, FINDING THE CUSTOMER HAD A LOT OF LIQUID ALL OVER THE TABLE DURING THE LAST CASE. BIOMED SAID THAT SOME LIQUID GOT INSIDE THE IMAGE INTENSIFIER TRANSDUCER BOARD, THIS WOULD EXPLAIN THE ISSUE. BIOMED REPORTS THAT HE WAS ABLE TO DRY OUT THE TRANSDUCER BOARD AND NOW THE TABLE / SYSTEM IS FULLY FUNCTIONAL WITHOUT ANY ISSUES.

    Description of Event or Problem · 1

    ON (B)(6) 2013, CUSTOMER STATES VIA PHONE THAT DURING AN UNDETERMINED PROCEDURE, THE FLUORO FAILED. STAFF WAS ABLE TO COMPLETE THE PROCEDURE BY BRINGING IN A PORTABLE AMX DR TO COMPLETE THE PROCEDURE. NO PT INFORMATION WAS AVAILABLE. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190689 HUT EXT DR FINAL ASSY-REVERSE IXR LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK