BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100

    MDR report key: 10155183 · Received June 15, 2020

    Report

    Report Number
    3001556265-2020-00009
    Event Type
    Malfunction
    Date Received
    June 15, 2020
    Date of Event
    June 8, 2020
    Report Date
    September 29, 2020
    Manufacturer
    AGFA N.V.
    Product Code
    IZL
    PMA / PMN Number
    K103597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AGFA SERVICE REPAIRED THE DX-D 100 SYSTEM BY REPLACING THE HANDGRIP, COLLIMATOR, DAP METER, AND DMC BOARD. THE DX-D 100 SYSTEM IS NOW WORKING AS INTENDED AND NO ADDITIONAL EVENTS HAVE BEEN REPORTED. AS PART OF THE DEVICE INVESTIGATION, THE HANDGRIP AND DMC BOARD WERE RETURNED TO THE SUPPLIER. DURING THE INVESTIGATION BY THE SUPPLIER, IT WAS CONFIRMED THE HANDGRIP KEYS HAD TWO PROBLEMS: 1. THE INTERNAL METALLIC PARTS WERE DISPLACED, AND 2. A CLEAR SHORT-CIRCUIT IN THE KEYS. THE SHORT-CIRCUIT AT THE HANDGRIP KEYS COULD BE CAUSED BY THE DISPLACED METAL PLATE. THE DMC BOARD WAS ALSO ANALYZED AND TESTED IN A DIFFERENT DX-D 100 SYSTEM. AFTER CONNECTING THE BOARD, THE DX-D 100 SYSTEM WAS SWITCHED ON AND IT STARTED MOVING BY ITSELF, BUT IT WAS BLOCKED AFTER LESS THAN ONE SECOND BECAUSE THE MOTORS' SUPPLY WAS CUT OFF. DUE TO MULTIPLE SYSTEM FAILURES AFTER CONNECTING THE DMC BOARD, THE EVENT'S SEQUENCE COULD NOT BE DETERMINED AS TO WHICH SPECIFIC PROBLEM CAUSED THE FAST MOVEMENT. THERE ARE NO ADDITIONAL CORRECTIVE ACTIONS FOR THIS EVENT. THERE HAS BEEN NO REPORTED HARM TO PATIENT OR USERS FOR THIS EVENT.

    Description of Event or Problem · 0

    THIS SUPPLEMENT REPORT #1 IS BEING SUBMITTED TO PROVIDE THE ROOT CAUSE AND ACTIONS TAKEN.SEE H10 FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED TO AGFA AN EVENT OF UNINTENDED MOVEMENT OF THEIR DX-D 100 SYSTEM. THE CUSTOMER REPORTED THE SYSTEM WAS PLUGGED IN AND CHARGING. THE DX-D 100 STARTED MOVING AND ROTATING ANTICLOCKWISE AT HIGH SPEED. AN EMPLOYEE MANAGED TO GRAB HOLD OF THE TUBE ARM AND PRESS THE EMERGENCY STOP SWITCH. AGFA SERVICE RESPONDED AND PERFORMED THE FOLLOWING CHECKS: OPENED MACHINE. LOOSENED NUTS ON WHEELS TO BE ABLE TO MOVE MACHINE FREELY. POWERED MACHINE AND LEFT WHEEL MOTOR SPINNING IN REVERSE AT FULL SPEED. TESTED BUMPER IN FRONT - NOT STOPPING MOVEMENT. DISCONNECTED DMC BOARD J1. CHECKED SEDECAL LOG FILES. CHARGING FOR X-RAY BATTERIES LOOKS FINE. COLLIMATOR BADLY DAMAGED. DAP METER CRACKED. RHS HANDLE ON TUBE BROKEN AS WELL AS THE WIRES FOR THE SLOW MOVEMENTS. PERFORMED EXPOSURE - TUBE ROTATED AND EXPOSED. COLLIMATOR LED STILL OK. INVESTIGATION IS UNDERWAY AND A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619918 DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 DX-D 100 MOBILE IZL AGFA N.V.

    Patients

    Seq Age Sex Outcome Treatment
    1