BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DDR ELEMENT

    MDR report key: 3648025 · Received January 13, 2014

    Report

    Report Number
    9614430-2014-00001
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    December 15, 2013
    Report Date
    January 13, 2014
    Manufacturer
    SWISSRAY INTERNATIONAL, INC.
    Product Code
    MQB
    PMA / PMN Number
    K110828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIFIC COMPONENT HAS NOT YET BEEN RETURNED FOR INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND TO BE CONFORMING. AFTER RETURN OF THE COMPONENT AND COMPLETION OF THE INVESTIGATION AN AMENDED REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT'S FACE WAS HIT BY THE DETECTOR GRID DURING A CHEST EXPOSURE PERFORMED WITH THE DDR ELEMENT. NO MEDICAL TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27522 DDR ELEMENT MQB SWISSRAY INTERNATIONAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other