BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDECAL

    MDR report key: 1610840 · Received February 8, 2010

    Report

    Report Number
    9617251-2010-00001
    Event Type
    Malfunction
    Date Received
    February 8, 2010
    Report Date
    February 2, 2010
    Manufacturer
    SEDECAL SA
    Product Code
    IZL
    PMA / PMN Number
    K012663
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEDECAL DID NOT DISCOVER THAT THE DEFECT COULD SHOW UP IN THE (B)(4) UNTIL (B)(4), 2010. WE ARE SORRY FOR THE DELAY IN REPORTING. UP TO 22 SIMILAR UNITS HAVE BEEN SOLD IN THE US MARKET. A CORRECTIVE ACTION HAS BEEN INITIATED TO FIELD UPDATE THESE UNITS. A SUPPLEMENTAL MDR REPORT WILL BE FILED WHEN THIS ACTION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THIS REPORT IS FOR A MOBILE X-RAY SYSTEM. THE SYSTEM HAS A MOTORIZED ASSIST BECAUSE THE DEVICE WOULD BE DIFFICULT TO MOVE WITHOUT IT BECAUSE OF ITS WEIGHT. IN ORDER TO IMPROVE THE MOTION SYSTEM, SEVERAL MOBILES HAVE BEEN UPDATED BY ADDING A DIGITAL MOTION CONTROL KIT. WE HAVE BEEN INFORMED THAT ONE SYSTEM WHICH WAS UPDATED BY ADDING THAT KIT MOVED WITHOUT THE OPERATOR REQUESTING THIS ACTION. THIS IS BEING REPORTED BECAUSE IF THIS WERE TO REOCCUR, IT IS POSSIBLE FOR SOMEONE TO BE INJURED. NO ONE WAS INJURED IN THIS CASE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEDECAL MOBILE X-RAY SYSTEM PRODUCT CODE IZL IZL SEDECAL SA EASY MOVING

    Patients

    Seq Age Sex Outcome Treatment
    1