BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100

    MDR report key: 4338536 · Received December 17, 2014

    Report

    Report Number
    9616389-2014-00033
    Event Type
    Malfunction
    Date Received
    December 17, 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

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. THIS REPORT IS FOR A 27TH EVENT FOR THE UNINTENDED MOVEMENT ISSUE WHEN USING A DX-D100 MOBILE UNIT. ON (B)(6) 2014, A DX-D100 UNIT WITH SERIAL # (B)(4) WAS BEING DRIVEN DOWN A RAMP BY A TECHNOLOGIST AT THE CUSTOMER SITE. AS THE UNIT CAME TO THE BOTTOM OF THE RAMP AND THE GROUND FLATTENED FOR ABOUT 20 FEET, THE TECHNOLOGIST CROSSED OVER A METAL THRESHOLD. WHILE CROSSING THE THRESHOLD, THE UNIT CAME TO A COMPLETE STOP AND THEN STARTED TO MOVE BACKWARDS. THE TECHNOLOGIST STATED HE WAS PRESSING FORWARD ON THE HANDLE BUT IT STILL MOVED BACKWARDS UNTIL IT RAN INTO THE DOOR, SMASHING HIS HAND BETWEEN THE UNIT AND THE DOOR WHERE IT FINALLY CAME TO A STOP. THE TECHNOLOGIST THEN SHUT DOWN THE UNIT AND CALLED THE AGFA SERVICE ENGINEER. THE AGFA SERVICE ENGINEER INSTRUCTED THE HOSPITAL BIOMED SERVICE TO MOVE THE DX-D100 UNIT TO THE AGFA SERVICE AREA AND INSTRUCTED THE TECHNOLOGIST NOT TO USE THE UNIT UNTIL THE SERVICEABILITY COULD BE VERIFIED. THE AGFA SERVICE ENGINEER DETERMINED THE VOLTAGE ON THE DMC BOARD WAS 3.2V AT TP10 AND 2.9V AT TP8, AND PROCEEDED TO ADJUST BOTH TO 2.5V. THE FIRMWARE VERSION ON THE DMC WAS CHECKED AND UPGRADED TO V11R3B4 AND THE ISOLATION KIT IS INSTALLED ON THE NEW BOARD. THE CHAIN TENSION WAS ALSO APPROXIMATELY 1.6KG ON BOTH SIDES, THEREFORE, WAS INCREASED TO 2.5KG ON EACH SIDE. FINALLY THE WHEELS WERE REPLACED WITH THE NATURAL RUBBER WHEELS. THE AGFA SERVICE ENGINEER DROVE THE UNIT AROUND FOR ABOUT AN HOUR AND THE UNIT SHOWED NO ISSUES WITH MOVEMENT OTHER THAN THE INTENDED MOVEMENT FOR THIS MOBILE UNIT. THE UNIT WAS PLACED BACK INTO SERVICE AND THE CUSTOMER WAS ADVISED TO STOP USING THE UNIT IF THEY EXPERIENCED ANY FURTHER UNINTENDED MOVEMENT. INVESTIGATION WILL CONTINUE FOR THIS OCCURRENCE. THE AGFA SERVICE ENGINEER INTERVIEWED THE TECHNOLOGIST AND ALSO CONFIRMED THE TECHNOLOGIST DID NOT RELEASE THE DEAD MAN SWITCH ON THE UNIT HANDLE UNTIL AFTER THE UNIT RAN INTO THE DOOR. THE TECHNOLOGIST DID HAVE THEIR HAND X-RAYED AND THE HAND WAS NOT BROKEN. NO PATIENT WAS INJURED DURING THIS EVENT, ALTHOUGH ALREADY STATED, THE USER'S HAND WAS HURT DURING THE INCIDENT. UNINTENDED MOVEMENT OF DX-D100S HAS ALREADY BEEN COMMUNICATED FOR A REPORTABLE CORRECTION TO THE FDA: (B)(4).

    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 DX-D100. (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)(6) 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 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828047 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