BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTABLE RADIOGRAPHY UNIT

    MDR report key: 16352924 · Received February 9, 2023

    Report

    Report Number
    MW5114843
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Date of Event
    December 26, 2022
    Report Date
    February 7, 2023
    Manufacturer
    AGFA NV
    Product Code
    IWZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A ROUTINE PATIENT IMAGING PROCEDURE USING AN AGFA DX-D 100 PORTABLE RADIOGRAPHIC UNIT, THE COUNTER WEIGHT CABLE SNAPPED AND THE HORIZONTAL ARM WITH ATTACHED X-RAY TUBE HEAD FELL TOWARD THE PATIENT BED. THE X-RAY HEAD COLLIMATOR LANDED ON THE BED RAILING AND THAT STOPPED THE FALL. NEITHER PATIENT NOR PERSONNEL WERE HARMED BY THE CABLE FAILURE. AFTER THE INCIDENT OUR ENGINEER INSPECTED THIS AGFA DX-D 100 AND DETERMINED THAT FOLLOWING THE COUNTER WEIGHT CABLE FAILURE, TENSION WAS NOT RELEASED FROM THE CABLE ATTACHED TO THE BACKUP SAFETY LATCH. SINCE TENSION WAS NOT RELEASED, THE BACKUP SAFETY LATCH DID NOT ENGAGE THE VERTICAL ARM AND STOP THE X-RAY HEAD FROM FALLING TOWARD THE BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607364 PORTABLE RADIOGRAPHY UNIT FILM, RADIOGRAPHIC IWZ AGFA NV DX-D100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown