BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUT EXT DR FINAL ASSY-STANDARD

    MDR report key: 3140042 · Received May 29, 2013

    Report

    Report Number
    1518293-2013-00119
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 18, 2013
    Report Date
    May 29, 2013
    Manufacturer
    LIEBEL - FLARSHEIM CO.
    Product Code
    IXR
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER CALLED SERVICE DISPATCH AND REPORTED NO IMAGES DURING PATIENT PROCEDURE. CUSTOMER CALLED BACK SAYING THEY HAD FIXED THE PROBLEM AND NO SERVICE WAS REQUIRED AT THIS TIME. ON (B)(6), PRODUCT MONITORING FOLLOW UP; CUSTOMER REPORTED THEY RE-BOOTED THE SYSTEM, AND SYSTEM IS FUNCTIONING WITHOUT ISSUE.

    Description of Event or Problem · 1

    ON (B)(6) 2013 CUSTOMER REPORTS VIA PHONE THAT DURING A STENT EXCHANGE ON (B)(6) MALE PATIENT THE FLUORO FAILED. THE PHYSICIAN FINISHED THE PROCEDURE WITH THE ENDOSCOPE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234115 HUT EXT DR FINAL ASSY-STANDARD IXR LIEBEL - FLARSHEIM CO. HUT EXT DR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR