BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CT INJECTOR CEILING SUPPORT

    MDR report key: 9473219 · Received December 13, 2019

    Report

    Report Number
    MW5091683
    Event Type
    Malfunction
    Date Received
    December 13, 2019
    Date of Event
    December 10, 2019
    Report Date
    December 12, 2019
    Manufacturer
    ACIST MEDICAL SYSTEMS, INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2019 A CEILING SUSPENDED CT INJECTOR SYSTEM, HAD A MECHANICAL FAILURE AT PIVOT POINT THAT ALLOWED THE INJECTOR AND A PORTION OF THE MOUNTING SYSTEM TO FAIL TO THE FLOOR. NO INJURY OCCURRED TO PTS OR STAFF. THE INJECTOR AND MOUNTING SYSTEM WAS MANUFACTURED BY ACIST MEDICAL A WHOLLY OWNED SUBSIDIARY OF BRACCO DIAGNOSTICS. ACIST CORPORATE HEADQUARTERS (B)(4); BRACCO DIAGNOSTICS INC. (B)(4); MFR REP HAD COMPLETED A PREVENTIVE MAINTENANCE (PM) ON THE UNIT ON 12/09/2019, AFTER REP LEFT THE SITE, OUR CT TECH FOUND A COUPLE SCREW PARTS ON THE FLOOR, BUT DID NOT FIND THE RELEVANCE TO THE INJECTOR SYSTEM OR THE PM AND PUT THE PARTS ASIDE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264739 CT INJECTOR CEILING SUPPORT INJECTOR AND SYRINGE, ANGIOGRAPHIC DXT ACIST MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1