BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDECAL

    MDR report key: 5499509 · Received March 14, 2016

    Report

    Report Number
    9617251-2016-00001
    Event Type
    Malfunction
    Date Received
    March 14, 2016
    Date of Event
    February 11, 2016
    Report Date
    March 16, 2016
    Manufacturer
    SEDECAL SA
    Product Code
    IZL
    PMA / PMN Number
    K103522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

    A RETROFIT KIT HAS BEEN DESIGNED FOR INSTALLATION ON ALL AFFECTED SYSTEMS. THIS WILL PREVENT THE PROBLEM FROM BEING REPEATED.

    Description of Event or Problem · 1

    THIS IS A MOBILE X-RAY SYSTEM. THERE IS A COMBINATION GENERATOR/TUBEHEAD/COLLIMATOR MOUNTED ON AN ARTICULATING ARM. DURING THE NORMAL USE OF THE SYSTEM THE WELD IN THE JOINT, ELBOW AT THE TOP PART OF THE FRAME WAS BROKEN. AS A RESULT OF THIS THE GENERATOR ASSEMBLY FELL TO THE GROUND. HAD THERE BEEN A PATIENT OR USER PRESENT UNDER THE GENERATOR ASSEMBLY WHEN IT FELL, THEY LIKELY WOULD HAVE BEEN INJURED. THIS UNIT (B)(4) WAS PRODUCED AT SEDECAL IN JUNE 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154369 SEDECAL MOBILE X-RAY SYSTEM IZL SEDECAL SA MOVIX 8.0 E+ (DRAGON)

    Patients

    Seq Age Sex Outcome Treatment
    1