BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 2913187 · Received January 8, 2013

    Report

    Report Number
    1518293-2012-00250
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 8, 2013
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TECH SUPPORT TROUBLESHOT WITH OPERATOR WHO WAS NOT ABLE TO MOVE THE TABLE DOWN DURING A PT PROCEDURE. TECH SUPPORT FOUND THE MESSAGE DISPLAYED ON THE UNIT SAID 'MONITOR SENSOR ALERT, PRESS OVERRIDE' AND HAD OPERATOR CHECK MONITOR SENSOR BY ACTUATING THE SAFETY BAR AND RE-TRYING. OPERATOR REPORTED THE ALERT WAS NOW REMOVED AND THE TABLE WILL NOW MOVE AS DESIRED.

    Description of Event or Problem · 1

    ON (B)(6): CUSTOMER REPORTS VIA PHONE TO PRODUCT MONITORING THAT TABLE WOULD NOT MOVE IN THE UP OR DOWN DIRECTION DURING A CYSTO RETROGRADE AND STENT PLACEMENT PROCEDURE ON A FEMALE PT, AGE OF PT UNK. CUSTOMER STATED THAT THEY HAD TO JIGGLE THE STATIONERY HANDLE, HOWEVER, TABLE WOULD NOT MOVE. PROCEDURE WAS COMPLETED WITHOUT INCIDENT. NO INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10092 HUT EXT DR FINAL ASSY-REVERSE IXR LIEBEL-FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK