BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTABLE X-RAY UNIT

    MDR report key: 7027726 · Received November 13, 2017

    Report

    Report Number
    MW5073318
    Event Type
    Injury
    Date Received
    November 13, 2017
    Date of Event
    October 6, 2017
    Report Date
    November 10, 2017
    Manufacturer
    SEDECAL
    Product Code
    IZL
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    X-RAY TECH WAS SETTING UP A RAD PRO PORTABLE X-RAY UNIT FOR A 72" SID CHEST X-RAY WHEN THE COLLIMATOR BECAME DETACHED FROM ITS MOUNTING RING. IT DID NOT COME IN CONTACT WITH THE PT. CLINICAL ENGINEERING (CE) INVESTIGATED AND DISCOVERED THE FOUR MOUNTING SCREWS WERE LOOSENING DURING NORMAL USAGE. CE APPLIED LOCTITE TO THESE SCREWS AND MADE SUBSEQUENT INSPECTION OF THESE SCREWS FOR SEVERAL DAYS AFTERWARDS - NO LOOSENING HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806096 PORTABLE X-RAY UNIT PORTABLE X-RAY UNIT IZL SEDECAL SM 40HF BDC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention