BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDRAD ANGIOGRAPHIC/CT INJECTOR

    MDR report key: 4180581 · Received October 15, 2014

    Report

    Report Number
    2520313-2014-00056
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 17, 2014
    Manufacturer
    BAYER MEDICAL CARE INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 09/23/2014, BAYER RADIOLOGY SERVICE CONFIRMED THAT THE WELD ON THE UPPER MAST OF THE PEDESTAL MOUNT WAS BROKEN. THE ARTERION PEDESTAL ASSEMBLY WAS REPLACED AND PROPER OPERATION WAS VERIFIED. BAYER RADIOLOGY PRODUCT ANALYSIS RECEIVED AND EXAMINED THE RETURNED PEDESTAL. VISUAL EXAMINATION DETERMINED THAT THE BROKEN WELD WAS CAUSED BY INSUFFICIENT WELDING OF THE UPPER MAST WHICH CAUSED AN INHERENT WEAKNESS IN THE STRUCTURE. BAYER RADIOLOGY HAS ISSUED A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) TO THE COMPONENT SUPPLIER FOR THIS ISSUE. THIS IS A FORMAL INVESTIGATION TO DETERMINE THE ROOT CAUSE AND APPLICABLE CORRECTION (S). AS PART OF THIS ACTIVITY, AN EFFECTIVENESS CHECK OF ANY RESULTING CORRECTIONS/IMPROVEMENTS WILL ALSO BE PERFORMED.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: THE ARM OF THE ARTERION INJECTOR SNAPPED OFF WHILE CONNECTED TO A PT CAUSING THE HEAD OF THE INJECTOR TO FALL. NO INJURY OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655237 MEDRAD ANGIOGRAPHIC/CT INJECTOR ANGIOGRAPHIC/CT INJECTOR DXT BAYER MEDICAL CARE INC. 3025982

    Patients

    Seq Age Sex Outcome Treatment
    1