BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100

    MDR report key: 10102687 · Received May 29, 2020

    Report

    Report Number
    3001556265-2020-00008
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    May 22, 2020
    Report Date
    August 4, 2020
    Manufacturer
    AGFA N.V.
    Product Code
    IZL
    PMA / PMN Number
    K103597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AGFA SERVICE RESPONDED AND CHECKED THE DX-D 100 SYSTEM. THE BATTERY MONITOR BOARD SHOWED MOTOR BATTERY LED AT BOTTOM FLASHING RED. ALL OTHER MOTOR CONTROL AND GENERATOR BATTERIES LEDS ARE OFF. WHEN THE SYSTEM WAS PLUGGED IN, THE BOTTOM LEDS ARE RED, MIDDLE LEDS WERE SOLID GREEN AND TOP 2 WERE FLASHING GREEN. THE BATTERY CHARGING VOLTAGES WERE ALL READING CORRECTLY WHEN THE SYSTEM WAS PLUGGED IN. AGFA SERVICE REPLACED AND ADJUSTED THE DMC BOARD, HOWEVER THE SYSTEM CONTINUED TO MOVE EVEN WHEN PLUGGED IN. AGFA SERVICE CONFIRMED AN ISSUE WITH THE FINE MOTOR POSITIONING CAPABILITY. NEW OVERLAY SWITCHES WERE INSTALLED AND TESTED SUCCESSFULLY. THE UNIT IS NOW WORKING AS INTENDED. THE CUSTOMER WAS PROVIDED DOCUMENTATION THAT OUTLINES RECOMMENDED CLEANING AND DISINFECTING PRODUCTS FOR AGFA DR EQUIPMENT. FURTHER INVESTIGATION BY AGFA AND THE SUPPLIER CONFIRMED DUE TO THE COVID 19 PANDEMIC THE CLEANING PROTOCOLS OF THE HOSPITALS HAVE BEEN MODIFIED AND THE CLEANING REQUIREMENTS SPECIFIED IN THE SYSTEM MANUAL ARE NOT BEING FOLLOWED. THE CUSTOMERS ARE MASSIVELY APPLYING DISINFECTANT LIQUIDS BY MEANS OF SPRAY PULVERIZED OVER THE HANDGRIP KEYS. THE LIQUID COMES INTO THE SYSTEM FROM THE SMALL GAPS BETWEEN THE OVERLAY OF THE KEYS AND THE HANDGRIPS. THIS LIQUID IS ACCUMULATED BETWEEN THE FLAT CABLE AND THE KEY'S OVERLAY MAKING A SHORTCIRCUIT IN THE OVERLAY AND ACTIVATING THE MOVEMENT. THERE HAS BEEN NO REPORTED HARM TO PATIENT OR USERS FOR THIS EVENT. AS A PREVENTIVE ACTION THE SUPPLIER IS INVESTIGATING SEVERAL METHODS FOR AVOIDING THAT THIS LIQUID COULD CAUSE A SHORT AT THE KEYS. THIS AREA COULD BE PROTECTED BY MEANS OF PLASTIC FILM, ADDING RESIN OR MODIFYING THE DESIGN OF THE OVERLAY. THIS PREVENTIVE ACTION IS NOT YET DEFINED.

    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 PARKED IN AN UNUSED XRAY ROOM, WHEN THE X-RAY TECH HEARD A BANG OR POP NOISE THEN A CRASH. WHEN THE TECH ENTERED THE ROOM, SHE FOUND THAT THE SYSTEM HAD RUN ITSELF BACKWARDS INTO THE X-RAY CONTROL PANEL. THE TECH ALSO REPORTED A BURNT ELECTRICAL SMELL. NO ONE WAS IN THE ROOM AT THE TIME AND THERE HAS BEEN NO REPORTED HARM TO PATIENT OR USER DURING THIS EVENT. THE CONTROL PANEL IN THE ROOM WAS NOT DAMAGED. INVESTIGATION IS UNDERWAY AND A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563625 DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 DX-D 100 MOBILE, IZL AGFA N.V.

    Patients

    Seq Age Sex Outcome Treatment
    1