BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-REVERSE

    MDR report key: 3973039 · Received April 29, 2014

    Report

    Report Number
    1518293-2014-00046
    Event Type
    Malfunction
    Date Received
    April 29, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    LIEBEL-FLARSHEIM CO
    Product Code
    IXR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT MONITORING FOLLOWED UP WITH THIS CUSTOMER WHO REPORTED THAT THE PROBLEM HAD BEEN RESOLVED. THE STAFF HAD PUSHED THE COMPUTER OVER WHEN REMOVING THE STIRRUPS AND HAD INADVERTENTLY PULLED THE POWER CORD OUT OF THE GIM BOX. BIOMED WAS ABLE TO FIND THIS (POWER CORD OUT) AND AFTER RESEATING THE POWER CORD, ALL FUNCTIONS RESUMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DURING A STONE REMOVAL WITH STENT PLACEMENT THE FLUORO FAILED WITH A GIM COMMUNICATION ERROR. THE PT WAS A (B)(6) YEAR OLD FEMALE. THE PHYSICIAN WAS ABLE TO LOCATE THE STONE FOR REMOVAL WITH THE FLUORO/IMAGE BEFORE THE FAILURE OCCURRED. HE WAS THEN ABLE TO REMOVE THE STONE WITH THE ENDOSCOPY EQUIPMENT AND PLACE THE STENT. NO FOLLOW UP X-RAY WAS REQUIRED. THE PROCEDURE WAS COMPLETED AND NO PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255581 HUT EXT DR FINAL ASSY-REVERSE IXR LIEBEL-FLARSHEIM CO HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR