BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    DX-D 100

    MDR report key: 17293147 · Received July 10, 2023

    Report

    Report Number
    3001556265-2023-00002
    Event Type
    Malfunction
    Date Received
    July 10, 2023
    Date of Event
    June 1, 2023
    Report Date
    May 27, 2025
    Manufacturer
    AGFA N.V.
    Product Code
    IZL
    PMA / PMN Number
    K103597
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AGFA SERVICE RESPONDED ON SITE TO INVESTIGATE THE ISSUE AND INSPECT THE SYSTEM. SYSTEM CHECKS WERE COMPLETED AS OUTLINED IN SERVICE BULLETIN 147. THE COLLIMATOR WAS REMOVED AND BOTH THE COLLIMATOR AND FLANGE WERE CHECKED AND SERVICE CONFIRMED THERE WAS NO DAMAGE. THE MOUNTING SCREWS AND TABS WERE CHECKED. THE COLLIMATOR WAS REATTACHED AND TESTED AS OUTLINED IN THE BULLETIN. ALL SYSTEM CHECKS WERE PASSED AND NO ADDITIONAL EVENTS HAVE BEEN REPORTED BY THE CUSTOMER. THERE ARE NO ADDITIONAL ACTIONS FOR THIS EVENT. THERE HAS BEEN NO REPORTED HARM TO PATIENT OR USER DURING THESE EVENTS.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENT REPORT #1 IS BEING SUBMITTED TO CORRECTLY IDENTIFY THIS REPORT AS PART OF THE VMSR (VOLUNTARY MALFUNCTION SUMMARY REPORTING) PROGRAM. SECTION REPORT IS UPDATED TO INCLUDE "VMSR". SECTION (B5) HAS BEEN UPDATED TO INCLUDE THE NUMBER OF EVENTS.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED WHEN RAISING THE TUBE FROM THE PARKING LATCH OF A DX-D 100 SYSTEM, THE SYSTEM COLLIMATOR FELL OFF. THE TUBE WAS POSITIONED OVER THE MONTOR AND WAS NOT OVER A PATIENT. THE COLLIMATOR DID NOT COME INTO CONTACT WITH A PATIENT OR USER.

    Description of Event or Problem · 0

    THIS SECTION (B5) HAS BEEN UPDATED TO INCLUDE THE NUMBER OF EVENTS. THIS REPORT SUMMARIZES NOE 1 /NOE MALFUNCTION EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2261167 DX-D 100 DX-D 100 MOBILE IZL AGFA N.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown