BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100

    MDR report key: 10045107 · Received May 11, 2020

    Report

    Report Number
    3001556265-2020-00004
    Event Type
    Malfunction
    Date Received
    May 11, 2020
    Report Date
    June 29, 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

    AGFA TECHNICAL SERVICE AND FIELD SERVICE WAS UNABLE TO IDENTIFY ANY COMPLAINTS OR LOGGED EVIDENCE RELATED TO THIS REPORTED INCIDENT. NO FURTHER INVESTIGATION CAN BE DONE. THE INCIDENT DESCRIBED IS OF AN ISOLATED CASE OF A RETAKE, WHICH ACCORDING TO AGFA'S RISK POLICY IS IN THE BROADLY ACCEPTABLE RANGE. THERE HAS BEEN NO REPORTED HARM TO PATIENT OR USERS FOR THIS EVENT. THERE ARE NO ADDITIONAL ACTIONS FOR THIS EVENT.

    Description of Event or Problem · 0

    THIS SUPPLEMENT REPORT #1 IS BEING SUBMITTED TO PROVIDE THE ROOT CAUSE AND ACTIONS TAKEN.SEE H10 FOR ADDITIONAL INFORMATION.

    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 "GENERATOR/DETECTOR" ERROR THAT READ, "DR DETECTOR 1708BH'S TEMPERATURE IS HIGHER THAN THE CALIBRATION TEMPERATURE RANGE (>29 DEGREES CELSIUS). IMAGE QUALITY MIGHT BE IMPACTED. [(B)(4)])" INVESTIGATION IS UNDERWAY AND A SUPPLEMENTAL REPORT WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509079 DIGITAL RADIOGRAPHY X-RAY SYSTEM DX-D100 DX-D 100 MOBILE IZL AGFA N.V.

    Patients

    Seq Age Sex Outcome Treatment
    1