BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100

    MDR report key: 10323479 · Received July 24, 2020

    Report

    Report Number
    3001556265-2020-00010
    Event Type
    Malfunction
    Date Received
    July 24, 2020
    Report Date
    October 30, 2020
    Manufacturer
    AGFA N.V.
    Product Code
    IZL
    PMA / PMN Number
    K103597
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE INVESTIGATION BY AGFA, THE ROOT CAUSE OF THE POWER CORD DAMAGE ISSUES IS CONFIRMED AS ROUGH OR INAPPROPRIATE USE WHEN THE CABLE REEL IS PULLED OUT AND IN. PREVIOUSLY THE CUSTOMER REPORTED A POWER CORD DAMAGE ISSUE RELATED TO THE CORD BEING RUN OVER REPEATEDLY OR THE TECH PULLING THE UNIT FROM THE OUTLET BY THE CORD. IF THE USER AT STAND-UP POSITION PULLS OUT OR IN THE CABLE VERY FAST, THE FRICTION BETWEEN CABLE AND PLASTIC COVER COULD CAUSE OVERHEATING OR WEAR ON THE CABLE COVER. JANUARY 2020, AGFA HAS INTRODUCED AN IMPROVED CABLE ROLLING MECHANISM FOR THE POWER CORD IN SERVICE BULLETIN NO. 120. A NEW SYSTEM WITH ROLLERS HAS BEEN DESIGNED FOR THE OUTPUT WINDOW OF THE POWER CORD REEL. WITH THIS NEW SYSTEM, THE FRICTION IS REDUCED WHEN THE USER TRIES TO PULL OUT THE CABLE. FOR THIS REPORTED EVENT, THE POWER CORD WAS REPLACED. THERE ARE NO FURTHER ACTIONS FOR THIS EVENT. THERE HAS BEEN NO REPORTED HARM TO PATIENT OR USERS FOR THIS EVENT.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 1

    AGFA RECEIVED A NOTIFICATION FROM FDA OF MEDWATCH REPORT # (B)(4) IN WHICH A CUSTOMER IN THE US REPORTED "X-RAY TECH REPORTED AFTER USING X-RAY MACHINE PORT #5 ON A PATIENT, HE NOTICED SMOKE COMING FROM OUTLET IN ROOM AFTER HE PLUGGED THE X-RAY UNIT. HE DECIDED TO PLUG IT INTO ANOTHER OUTLET- THAT SHARED SAME LINE- BUT SMOKE STILL OCCURRED. THE ENGINEER CAME AND REPLACED PART (POWER CORD) TWO DAYS LATER. THIS IS THE 2ND INCIDENT OF ELECTRICAL ISSUE WITH THE UNIT WHICH HAPPENED PRIOR ON [DATE REDACTED]." INVESTIGATION IS UNDERWAY AND A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783237 DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 DX-D 100 MOBILE IZL AGFA N.V.

    Patients

    Seq Age Sex Outcome Treatment
    1