BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100

    MDR report key: 6124319 · Received November 23, 2016

    Report

    Report Number
    9616389-2016-00009
    Event Type
    Malfunction
    Date Received
    November 23, 2016
    Date of Event
    November 16, 2016
    Report Date
    November 23, 2016
    Manufacturer
    AGFA HEALTHCARE N.V.
    Product Code
    IZL
    PMA / PMN Number
    K103597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WE ARE REPORTING THIS MDR REPORTABLE EVENT ON NOVEMBER 23, 2016. THE CUSTOMER REPORTED TO AGFA THAT WHEN USING THEIR DX-D100 UNIT, THEY EXPERIENCED UNINTENDED MOVEMENT. THIS REPORT IS FOR THE 1ST OF TWO EVENTS FOR UNINTENDED MOVEMENT FOR THE SAME UNIT AT THIS SITE. ON (B)(6) 2016, WHEN THE OPERATOR ATTEMPTED TO BACK THE UNIT OUT FROM THE AREA THE UNIT NORMALLY SITS WHEN NOT USED, THE UNIT PUSHED THE OPERATOR BACK. THE UNIT TURNED TO THE RIGHT, EVEN WHEN THE HANDLE WAS RELEASED. THE OPERATOR HIT THE KILL SWITCH AND LEFT THE UNIT IN THE HALLWAY IN A POWERED DOWN STATE. THE SECOND EVENT IS REPORTED IN FDA MDR 9616389-2016-00010. THE SECOND EVENT OCCURRED ON (B)(6) 2016, WHEN THE BIO-MED STAFF WAS MOVING THE UNIT FROM THE HALLWAY TO THE ELEVATOR IN ORDER TO TAKE THE UNIT OUT OF SERVICE AND REQUEST A SERVICE CALL FOR THE UNIT. THE UNIT DROVE FORWARD OKAY. WHEN THE UNIT WAS BACKED INTO THE ELEVATOR, THE UNIT PUSHED BACKWARDS TOWARDS THE RIGHT EVEN WHEN THE HANDLE WAS RELEASED. THE BIO-MED STAFF HIT THE KILL SWITCH. ON NOVEMBER 21, 2016, AGFA SERVICE REPLACED A DEFECTIVE LEFT GAUGE AND CHECKED ALL CABLE CONNECTIONS AND ARRESTORS ON THE BOTTOM OF THE UNIT. THE UNIT IS NOW WORKING AS INTENDED AND THERE HAVE BEEN NO FURTHER REPORTS OF UNINTENDED MOVEMENT. THERE HAS BEEN NO REPORTED HARM TO PATIENT OR USER DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775048 DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 DX-D 100 MOBILE IZL AGFA HEALTHCARE N.V. DX-D100 MOBILE

    Patients

    Seq Age Sex Outcome Treatment
    1