BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANON MEDICAL PORTABLE X-RAY MACHINE

    MDR report key: 12893535 · Received November 29, 2021

    Report

    Report Number
    MW5105662
    Event Type
    Malfunction
    Date Received
    November 29, 2021
    Date of Event
    November 8, 2021
    Report Date
    November 24, 2021
    Manufacturer
    SEDECAL S. A.
    Product Code
    IZL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPORT OF X-RAY ARM LOCKED IN POSITION. UPON FURTHER INVESTIGATION IT WAS DETERMINED THAT THE BOLT THAT SECURES THE COUNTER SPRING TO THE BASE OF THE UNIT FAILED. THE HEAD OF THE BOLT SEPARATED FROM THE SHAFT CAUSING THE SPRING TO RELEASE WITHIN THE COLUMN. DEPENDING ON POSITION OF COLUMN, THIS COULD POSE A RISK TO OPERATOR OR PATIENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786148 CANON MEDICAL PORTABLE X-RAY MACHINE SYSTEM, X-RAY, MOBILE IZL SEDECAL S. A. SM-40HF-B-D-VIR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown