BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100

    MDR report key: 8279115 · Received January 25, 2019

    Report

    Report Number
    9616389-2019-00006
    Event Type
    Malfunction
    Date Received
    January 25, 2019
    Date of Event
    January 24, 2019
    Report Date
    March 4, 2019
    Manufacturer
    AGFA N.V.
    Product Code
    IZL
    PMA / PMN Number
    K103597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE INVESTIGATION BY AGFA AND THE SUPPLIER, THE SYSTEM WAS INSPECTED. THE INITIAL ASSESSMENT CONFIRMED THERE WAS NO CRACKED OR BROKEN ITEMS. THE EXISTING FLANGE APPEARED TO BE IN GOOD CONDITION, THE LIP OF THE FLANGE WHERE THE COLLIMATOR WOULD BE SECURED DID NOT HAVE ANY DAMAGE. THE COLLIMATOR TABS WERE INTACT WITH NO VISIBLE DAMAGE, ALTHOUGH THERE WAS SOME BRASS SHAVINGS THAT COULD BE SEEN. ALSO IT WAS NOTICED THE TABS WERE NOT FULLY ENGAGED. THE FLANGE WAS REPLACED WITH A NEW FLANGE. THE COLLIMATOR WAS THEN SUCCESSFULLY SECURED TO THE FLANGE. THE SYSTEM WAS TESTED TO MAKE SURE THE COLLIMATOR WAS SECURED AND THEN THE SYSTEM WAS RELEASED TO CUSTOMER. THE ROOT CAUSE HAS BEEN DETERMINED AS THE INCORRECT MOUNTING OF THE COLLIMATOR. THE BIOMEDICAL ENGINEER LOOSENED THE COLLIMATOR SCREWS WHICH CAUSED THE COLLIMATOR TO FALL. THIS EVENT WAS NOT ATTRIBUTED TO INCORRECT SERVICE INSTALLATIONS. THERE ARE NO CORRECTIVE ACTIONS FOR THIS EVENT. THE DX-D 100 SYSTEMS ALREADY CONTAIN AN EXPLICIT CAUTION WARNING CONCERNING MECHANICAL COLLIMATOR INSTALLATION "CAREFULLY FOLLOW THE MOUNTING INSTRUCTIONS AND MAKE SURE THAT THE COLLIMATOR IS CORRECTLY ASSEMBLED. INCORRECT MOUNTING COULD BE DANGEROUS: IT COULD CAUSE THE COLLIMATOR TO FALL OR TO OPERATE INACCURATELY". AN ADDITIONAL PREVENTIVE ACTION WILL BE TAKEN TO INCLUDE A SERVICE INSTRUCTION WITH ALL DELIVERIES OF COLLIMATORS. THERE HAS BEEN NO REPORTED PATIENT HARM FOR THIS EVENT.

    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

    A CUSTOMER IN THE US REPORTED TO AGFA WHEN USING THEIR DX-D 100 SYSTEM THE COLLIMATOR FELL FROM THE SYSTEM. THE CUSTOMER REPORTED IN PREPARATION TO IMAGE A PATIENT AFTER HEART SURGERY, THE COLLIMATOR FELL OFF AND HIT THE PATIENT IN THE ABDOMEN. THE PATIENT, WHO WAS MEDICATED FROM SURGERY, INDICATED THEY WERE NOT HURT. THE UNIT HAS BEEN REMOVED FROM SERVICE. INVESTIGATION IS UNDERWAY AND A SUPPLEMENTAL REPORT WILL BE PROVIDED. THERE HAS BEEN NO REPORTED ACTUAL HARM TO PATIENT OR USER DURING THESE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69759 DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 DX-D 100 MOBILE IZL AGFA N.V.

    Patients

    Seq Age Sex Outcome Treatment
    1