BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 8240669 · Received January 11, 2019

    Report

    Report Number
    1518293-2018-00046
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Date of Event
    December 11, 2018
    Report Date
    December 11, 2018
    Manufacturer
    LIEBEL-FLARSHEIM
    Product Code
    IXR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    THIS INCIDENT WAS REPORTED ON (B)(6) 2018 AS A DEVICE MALFUNCTION RESULTING IN NO IMAGES WHEN STEPPING ON FLUORO FOOT PEDAL. THE REPORTER STATED THAT AN ERROR IMAGE WAS NOT TAKEN, AND THAT RELEASE FOOT PEDAL SEDECAL SCREEN WAS POWERED OFF. THE EVENT DID OCCUR DURING A PROCEDURE AND THE PROCEDURE WAS NOT COMPLETED AND HAD TO BE RESCHEDULED. REPORTER STATED THAT THE SEDECAL CONSOLE IS SHUTTING DOWN DURING THE ATTEMPTED EXPOSURES, AND PHONE CALL RECEIVER REQUESTED THAT REPORTER ATTEMPT TO TAKE AN EXPOSURE AND THE MESSAGE CENTER SHOWED CHECK COLLIMATOR. PHONE CALL RECEIVER HAD REPORTER TURN PBL OVERRIDE, WHICH RESULTED IN SUCCESSFUL EXPOSURE, THEN TURNED BACK SYSTEM RETURNED TO NORMAL OPERATION. FOLLOWING THIS, THE REPORTER CALLED BACK ON (B)(6) 2018 AND STATED THAT THE FACILITY HAS NOT HAD ANY ISSUES FROM THE LAST CALL UNTIL THE DAY OF THE FOLLOW-UP CALL, AND STATED THAT THE SEDECAL TOUCH SCREEN, THE OLDER ONE, TURNED ITSELF OFF AGAIN. THE REPORTER WAS TOLD THAT THE FIX WOULD BE A SEDECAL CONSOLE UPGRADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35463 HUT EXT DR FINAL ASSY-REVERSE HUT EXT DR FINAL ASSY-REVERSE IXR LIEBEL-FLARSHEIM 404007

    Patients

    Seq Age Sex Outcome Treatment
    1