BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 5081647 · Received September 16, 2015

    Report

    Report Number
    1518293-2015-00093
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 1, 2015
    Manufacturer
    LIEBEL FLARSHEIM
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    TECH SERVICE SPOKE WITH BIOMED WHO REPORTED THAT THE INFIMED I5 POWERS UP BUT THE MONITOR SCREEN WAS COMPRESSED TO THE TOP RIGHT CORNER ON BOTH THE CONTROL ROOM MONITOR AND TABLE MONITOR. BIOMED HAD TRIED RESETTING GRAPHICS AND THE IAPDB CARDS IN THE TOWER BUT THE ISSUE REMAINED. TECH SERVICE THOUGHT THE PROBLEM WOULD BE THE IAPDB BOARD, BUT THE BIOMED BELIEVED THE ISSUE WAS THE VIDEO CARD AND WANTED THE PART NUMBER FOR A REPLACEMENT, SO SERVICE GAVE BIOMED REPLACEMENT PART NUMBER 710318 FOR A CARD REPLACEMENT IF THAT WAS THE ISSUE. ON A FOLLOW UP PHONE CALL, THE CUSTOMER REPORTED THAT HE WAS ABLE TO REPAIR THE SYSTEM BY REPLACING THE IAPD BOARD AND NOW THE SYSTEM WAS FULLY FUNCTIONAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DURING AN UNKNOWN PROCEDURE THE FLUORO FAILED. PATIENT WAS MOVED TO ANOTHER ROOM TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. NO REPORTED INJURY. NO ADDITIONAL DETAILS ARE KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611395 HUT EXT DR FINAL ASSY-STANDARD HUT EXT DR FINAL ASSY-STANDARD IXR LIEBEL FLARSHEIM HUT EXT DR FINAL ASSY-STANDARD

    Patients

    Seq Age Sex Outcome Treatment
    1