BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 5481544 · Received March 4, 2016

    Report

    Report Number
    1518293-2016-00018
    Event Type
    Malfunction
    Date Received
    March 4, 2016
    Date of Event
    February 22, 2016
    Report Date
    February 22, 2016
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    TECH SERVICE TROUBLESHOT WITH CUSTOMER WHO CALLED REPORTING A GENERATOR INTERFACE MALFUNCTION (GIM) COMMUNICATION FAILURE SHOWING UP ON THE INFIMED COMPUTER SCREEN. TECH SERVICE TRIED HAVING THE CUSTOMER POWER CYCLE THE GIM BUT DID NOT RESOLVE THE GIM COMMUNICATION ERROR MESSAGE. TECH SERVICE THEN SPOKE TO THE BIOMED AND DETERMINED THE GIM HAD FAILED, AND PROVIDED HIM PART NUMBER (B)(4) FOR A REPLACEMENT GIM. THE BIOMED ORDERED THE REPLACEMENT GIM, SERVICE INSTRUCTED CUSTOMER ON HOW TO UPDATE THE VERSION TO MAKE IT COMPATIBLE WITH THEIR SYSTEM AND THE BIOMED COMPLETED THE INSTALLATION. BIOMED THEN TESTED FOR FUNCTIONALITY AND TOLD SERVICE THAT THE SYSTEM WAS REPAIRED AND THAT THE GIM WAS COMMUNICATING WITH THE SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE SYSTEM FAILED WITH A GIM ERROR DURING A PROCEDURE. STAFF WAS ABLE TO MOVE THE PATIENT TO ANOTHER ROOM AND COMPLETE THE PROCEDURE WITHOUT INCIDENT. NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138311 HUT EXT DR FINAL ASSY-REVERSE HUT EXT DR FINAL ASSY-REVERSE IXR LIEBEL FLARSHEIM HUT EXT DR FINAL ASSY-REVERSE

    Patients

    Seq Age Sex Outcome Treatment
    1