BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100

    MDR report key: 4262785 · Received November 19, 2014

    Report

    Report Number
    9616389-2014-00031
    Event Type
    Malfunction
    Date Received
    November 19, 2014
    Date of Event
    January 15, 2015
    Report Date
    February 2, 2015
    Manufacturer
    AGFA HEALTHCARE N.V.
    Product Code
    IZL
    PMA / PMN Number
    K103597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    RELATED TO NEW ARRESTOR TO PREVENT ELECTROSTATIC DISCHARGE

    Description of Event or Problem · 1

    THIS MEDIAL DEVICE REPORT IS BEING SUBMITTED DUE TO AN ADDITIONAL SAME ISSUE THAT WAS ORIGINALLY REPORTED IN MDR REPORT, FDA # 9616389-2013-00003. UNINTENDED MOVEMENT HAS OCCURRED ON THE SAME UNIT DESCRIBED IN THIS MDR REPORT AS WAS ALSO REPORTED RECENTLY VIA MDR 9616389-2014-00029 ON OCTOBER 27, 2014. THIS REPORT IS FOR A 25TH EVENT FOR THE UNINTENDED MOVEMENT ISSUE WHEN USING A DX-D100 MOBILE UNIT. ON (B)(6) 2014, THE SAME UNIT, WITH SERIAL # (B)(4), ALREADY REPLACED WITH A NEW DMC BOARD, EXPERIENCED AN ADDITIONAL EVENT OF UNEXPECTED ACCELERATION AFTER EXITING AN ELEVATOR. THE SAME TECHNOLOGIST WHO WAS DRIVING THE DX-D100 UNIT DESCRIBED IN MDR# 9616389-2014-00029, IS THE SAME TECHNOLOGIST WHO EXPERIENCED THIS NEW EVENT OF SIMILAR ACCELERATION, WHILE AGAIN DRIVING THE SAME UNIT OFF OF THE ELEVATOR. THE SYSTEM WAS CHECKED, VOLTAGES AND WIRES WERE INSPECTED AND NO PROBLEMS WERE IDENTIFIED. AGFA DE-INSTALLED THE DX-D100 UNIT WITH SERIAL # (B)(4), AND WILL REPLACE WITH A NEW UNIT. AGFA WILL CONTINUE TO WORK WITH SEDECAL, AS THE DE-INSTALLED UNIT WILL BE SHIPPED BACK TO SEDECAL FOR FURTHER INVESTIGATION. UNINTENDED MOVEMENT OF DX-D100S HAS ALREADY BEEN COMMUNICATED FOR A REPORTABLE CORRECTION TO THE FDA: (B)(4). NO PATIENT OR USER WAS INJURED DURING THIS EVENT.

    Description of Event or Problem · 1

    (B)(4), AGFA'S SUPPLIER, VISITED THE SITE DOCUMENTED IN THIS MEDICAL DEVICE REPORT AND FURTHER INVESTIGATED THE ISSUES RELATED TO AND REPORTED AS UNINTENDED MOVEMENT OF THE (B)(4). (B)(4) PERFORMED SEVERAL ELECTROSTATIC TESTS. ONE TEST WAS TO EMULATE A USER WHO HAS STORED AN ELECTROSTATIC ENERGY IN HIS OR HER BODY TO DETERMINE IF THE STORED ENERGY IS DISCHARGED THROUGH TO THE GROUNDED EQUIPMENT AND POSSIBLY AFFECTING THE NORMAL OPERATION OF THE EQUIPMENT. (B)(4) PROCEEDED TO TEST THE COMPATIBILITY OF SEVERAL TYPES OF FLOORING WITHIN THE HOSPITAL ENVIRONMENT. (B)(4) DISCOVERED AND CONFIRMED THE CAUSE FOR THE UNINTENDED MOVEMENT INITIALLY REPORTED FOR THIS EVENT WAS DIFFERENT FROM PREVIOUSLY REPORTED UNINTENDED MOVEMENT. THE MOBILE UNIT ITSELF WAS ACTUALLY BUILDING UP STORED ENERGY AND GETTING CHARGED. ON (B)(4) 2015, (B)(4) REPORTED TO AGFA THE CAUSE WAS INDEED DIFFERENT. IT IS RELATED TO AN ELECTROSTATIC DISCHARGE WHEN DRIVING OVER METAL THRESHOLDS OR WHILE ENTERING/LEAVING AN ELEVATOR. (B)(4) WILL BE IMPLEMENTING A CORRECTIVE ACTION RELATED TO A NEW ARRESTOR. CORRECTIVE ACTIONS FOR THIS SITE ISSUE WILL BE DOCUMENTED VIA PROBLEM RECORD, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749938 DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 DX-D 100 MOBILE WIRELESS IZL AGFA HEALTHCARE N.V. DX-D100 MOBILE WIRELESS DR

    Patients

    Seq Age Sex Outcome Treatment
    1