BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100

    MDR report key: 10102191 · Received May 29, 2020

    Report

    Report Number
    3001556265-2020-00006
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    May 18, 2020
    Report Date
    July 17, 2025
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGFA SERVICE RESPONDED AND CHECKED THE DX-D 100 SYSTEM. THE DMC BOARD AND LEFT/RIGHT HANDLE GAUGE ADJUSTMENT WERE ALL IN THE RANGE AS PER THE SYSTEM SERVICE MANUAL. THE HANDGRIP LEFT/RIGHT FINE POSITIONING SWITCHES WERE CHECKED AND IT WAS CONFIRMED THAT ONE OF THE SWITCHES ON LEFT HANDGRIP WORKS AND THE REST WERE NOT WORKING. AGFA SERVICE REPLACED LEFT AND RIGHT HANDGRIP SWITCH. THE SYSTEM FUNCTIONALITY WAS CHECKED AND IT WORKED PROPERLY. THE UNIT IS NOW WORKING AS INTENDED. 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 SHORT CIRCUIT 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 UNIT MOVED ON ITS OWN THREE TIMES IN TWO DAYS. AGFA IS REPORTING EACH EVENT. THIS MDR REPORT IS FOR THE SECOND EVENT. THE DX-D 100 SYSTEM WAS REPORTED TO MOVE FORWARD AT A SLOW SPEED IN ON ONE OCCURENCE. THE SYSTEM WAS REPORTED TO MOVE ONCE WHEN IT WAS CLOSE BY A PATIENT STRETCHER IN THE SECOND OCCURENCE. IN THE THIRD OCCURENCE THE SYSTEM WAS REPORTED TO MOVE WHEN IT WAS PLUGGED IN. INVESTIGATION IS UNDERWAY AND A SUPPLEMENTAL REPORT WILL BE PROVIDED. THERE HAS BEEN NO REPORTED HARM TO PATIENT OR USER DURING THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567289 DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 DX-D 100 MOBILE, IZL AGFA N.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown