BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100

    MDR report key: 8231255 · Received January 9, 2019

    Report

    Report Number
    9616389-2019-00003
    Event Type
    Malfunction
    Date Received
    January 9, 2019
    Date of Event
    December 30, 2018
    Report Date
    February 14, 2019
    Manufacturer
    AGFA N.V.
    Product Code
    IZL
    PMA / PMN Number
    K103597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AGFA SERVICE RESPONDED AND SUSPECTED A DEFECTIVE DMC BOARD. AGFA SERVICE REPLACED THE DMC BOARD. THE UNIT WAS THEN TESTED AND WAS DRIVING GOOD. THE UNIT WAS RELEASED TO THE CUSTOMER. DURING FURTHER INVESTIGATION BY AGFA AND ITS SUPPLIER, THE DEFECTIVE DMC BOARD WAS INSPECTED. DURING THE INSPECTION IT WAS CONFIRMED THERE WAS LIQUID DAMAGE PRESENT ON THE BOARD. THE CAUSE OF THE LIQUID DAMAGE IS ATTRIBUTED TO THE USER. THE UNIT IS NOW WORKING AS INTENDED AND NO FURTHER EVENTS HAVE BEEN REPORTED. THERE HAS BEEN NO REPORTED PATIENT HARM FOR THIS EVENT. AGFA HEALTHCARE NV HAS RECENTLY CHANGED THE COMPANY STRUCTURE INTO TWO LEGAL ENTITIES, NAMED AGFA HEALTHCARE AND AGFA NV. THIS REPORT IS FOR AGFA N. V. AGFA N.V'S OWNER OPERATOR NUMBER IS (B)(4). AGFA N.V. IS CURRENTLY AWAITING THE ASSIGNMENT OF A FDA REGISTRATION NUMBER. THIS REPORT HAS BEEN SUBMITTED VIA THE MANUFACTURER REGISTRATION NUMBER 9616389 FOR AGFA HEALTCARE N.V.

    Description of Event or Problem · 0

    THIS SUPPLEMENT REPORT #1 IS BEING SUBMITTED TO PROVIDE THE ROOT CAUSE AND ACTIONS TAKEN.

    Additional Manufacturer Narrative · 1

    AGFA HEALTHCARE NV HAS RECENTLY CHANGED THE COMPANY STRUCTURE INTO TWO LEGAL ENTITIES, NAMED AGFA HEALTHCARE AND AGFA NV. THIS REPORT IS FOR AGFA N. V. AGFA N.V'S OWNER OPERATOR NUMBER IS (B)(4). AGFA N.V. IS CURRENTLY AWAITING THE ASSIGNMENT OF A FDA REGISTRATION NUMBER. THIS REPORT HAS BEEN SUBMITTED VIA THE MANUFACTURER REGISTRATION NUMBER (B)(4) FOR AGFA HEALTHCARE N.V.

    Description of Event or Problem · 1

    ON (B)(6) 2018, A CUSTOMER IN THE US REPORTED TO AGFA THAT WHEN USING THEIR DX-D 100 SYSTEM, THEY EXPERIENCED UNINTENDED MOVEMENT. THERE WERE THREE (3) EVENTS OF UNINTENDED MOVEMENT. AGFA IS REPORTING EACH EVENT. THIS MDR REPORT IS FOR THE THIRD EVENT. DURING THE FIRST EVENT, A TECH ATTEMPTED TO COMPLETE A PORTABLE EXAM, BUT WHEN THE TECH STARTED TO MOVE THE DX-D 100, THE SYSTEM TOOK OFF AND CRASHED INTO A CHAIR, BREAKING THE CHAIR. THE TECH ENGAGED THE EMERGENCY STOP AND ASKED ANOTHER TECH TO LOOK AT THE SYSTEM. THE FIRST EVENT HAS BEEN REPORTED TO FDA VIA AGFA REFERENCE NUMBER 9616389-2019-00001. DURING THE SECOND EVENT, THE SECOND TECH TRIED TO MOVE THE DX-D 100 SYSTEM, BUT THE SYSTEM ONCE AGAIN TOOK OFF AND CRASHED INTO SOME WHEELCHAIRS. THE TECH ENGAGED THE EMERGENCY STOP AND SHUT THE SYSTEM DOWN. THE SECOND EVENT HAS BEEN REPORTED TO FDA VIA AGFA REFERENCE NUMBER 9616389-2019-00002. DURING THE THIRD EVENT, THE SECOND TECH REBOOTED THE DX-D 100 SYSTEM, AND TRIED TO MOVE THE DX-D 100 AGAIN. THE SYSTEM AGAIN TOOK OFF AND RAN INTO A WALL. THE TECH ENGAGED THE EMERGENCY STOP AND DID NOT MOVE THE SYSTEM AGAIN. 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
    23414 DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 DX-D 100 MOBILE IZL AGFA N.V.

    Patients

    Seq Age Sex Outcome Treatment
    1