BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANON

    MDR report key: 15986297 · Received December 15, 2022

    Report

    Report Number
    9617251-2022-00006
    Event Type
    Malfunction
    Date Received
    December 15, 2022
    Date of Event
    October 12, 2022
    Report Date
    December 14, 2022
    Manufacturer
    SEDECAL
    Product Code
    IZL
    UDI-DI
    08436046002456
    PMA / PMN Number
    K192936
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION HAS BEGUN AND USERS ARE BEING NOTIFIED OF THE PROBLEM.

    Description of Event or Problem · 0

    TECHNICIAN MM , RADIOLOGY TECHNOLOGIST, NIGHT SHIFT WAS COMING DOWN RAMP FROM HPMC ED TO RADIOLOGY DEPARTMENT WITH CANON SOLTUS 450ST MOBILE X-RAY UNIT "K", SN# (B)(4) AND IT SUDDENLY WENT INTO REVERSE WITHOUT WARNING. MARLON WAS PINNED AGAINST RAILING WALL AND INJURED HAND.. THE X-RAY UNIT WAS DAMAGED - THE PLASTIC FRAME UNDER HANDLE IN FRONT BROKE OFF., RADIOLOGY TECHNOLOGIST, NIGHT SHIFT WAS COMING DOWN RAMP FROM HPMC ED TO RADIOLOGY DEPARTMENT WITH CANON SOLTUS 450ST MOBILE X-RAY UNIT "K", SN# (B)(4) AND IT SUDDENLY WENT INTO REVERSE WITHOUT WARNING. MM WAS PINNED AGAINST RAILING WALL AND INJURED HAND.. THE X-RAY UNIT WAS DAMAGED - THE PLASTIC FRAME UNDER HANDLE IN FRONT BROKE OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2571072 CANON MOBILE DIGITAL DIAGNOSTIC X-RAY SYSTEM IZL SEDECAL SEDECAL SOLTUS 450 08436046002456

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown