BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100

    MDR report key: 8066586 · Received November 13, 2018

    Report

    Report Number
    9616389-2018-00016
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    October 22, 2018
    Report Date
    February 13, 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

    THE ROOT CAUSE HAS BEEN DETERMINED. THE SCREWS FOR THE LOCK ASSEMBLY BECAME LOOSENED. AGFA SERVICE VERIFIED THE WASHER AND LOCK WASHER WERE IN PLACE AND REATTACHED THE LOCKING MECHANISM USING LOCK TIGHT ON SCREW THREADS. 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 10058267. 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 #1IS BEING SUBMITTED TO PROVIDE THE ROOT CAUSE AND ACTIONS TAKEN.

    Additional Manufacturer Narrative · 1

    DUE TO RECENT CHANGES, AGFA (B)(4) IS NOW SEPARATE FROM AGFA HEALTHCARE (B)(4). AGFA (B)(4) IS CURRENTLY AWAITING THE ASSIGNMENT OF A FDA REGISTRATION NUMBER. THIS REPORT HAS BEEN SUBMITTED VIA THE MANUFACTURER REGISTRATION NUMBER 9616389 FOR AGFA HEALTCARE (B)(4). FOR THIS REPORT, THE MFR REPORT # 9616389-2018-00016 SHOULD BE 10058267-2018-00001, HOWEVER DUE TO TECHNICAL RESTRAINTS OF THE ESUBMITTER SYSTEM, THE AGFA (B)(4) OWNER/OPERATOR NUMBER COULD NOT BE ENTERED INTO THE MFR REPORT # FIELD.

    Description of Event or Problem · 1

    A CUSTOMER IN THE US REPORTED TO AGFA WHEN USING THEIR DX-D 100 SYSTEM A COMPONENT FELL FROM THE SYSTEM. THE CUSTOMER REPORTED THE LOCKING MECHANISM FOR THE TUBE DROPPED OFF THE TUBE DURING AN EXAM. THE UNIT HAS BEEN REMOVED FROM SERVICE. 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
    905832 DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 DX-D 100 MOBILE IZL AGFA N.V.

    Patients

    Seq Age Sex Outcome Treatment
    1