BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADPRO

    MDR report key: 12518519 · Received September 23, 2021

    Report

    Report Number
    12518519
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Date of Event
    August 30, 2021
    Report Date
    September 21, 2021
    Manufacturer
    CANON MEDICAL SYSTEMS USA, INC.
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RADIOLOGY HAD JUST FINISHED TAKING X-RAYS IN A PATIENT ROOM. WHEN THEY WERE BACKING THE PORTABLE X-RAY MACHINE OUT OF THE ROOM, IT SPARKED AND THEN A STRONG SMELL OF SMOKE WAS PRESENT. THEY WERE ABLE TO SAFELY REMOVE THE PORTABLE [X-RAY] FROM THE PATIENT ROOM AND DRIVE IT TO RADIOLOGY WHERE BIOMED REMOVED IT FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1418996 RADPRO SYSTEM, X-RAY, MOBILE IZL CANON MEDICAL SYSTEMS USA, INC. SM-40HF-B-D-C

    Patients

    Seq Age Sex Outcome Treatment
    1