BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10

    MDR report key: 20321232 · Received September 27, 2024

    Report

    Report Number
    3003768277-2024-05487
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    September 18, 2024
    Report Date
    January 22, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    PMA / PMN Number
    K041949
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. A PHILIPS REMOTE SERVICE ENGINEER (RSE) RECEIVED A COMPLAINT INDICATING THAT INTERNAL MONITOR IMAGES DISAPPEARING. ACCORDING TO THE COMMENTS IN THE CSR, THE CALL WAS CLOSED WITHOUT ANY ACTION FROM PHILIPS DUE TO UNRESOLVED ADMINISTRATIVE ISSUES ON THE CUSTOMER. REMOTE SERVICE ENGINEER (RSE) DID NOT CONTACT THE CUSTOMER FOR REMOTE DIAGNOSIS AND THEREFORE, RSE IS NOT AWARE OF THE DETAILS OF THE CALL. NO WORK PERFORMED BY PHILIPS. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT IMAGES ON THE SYSTEM'S INTERNAL MONITOR DISAPPEAR, WHICH CAN IMPACT IMAGING. NO HARM TO THE PATIENT OR USER WAS REPORTED. WE ARE CONSERVATIVELY REPORTING THIS EVENT AS THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1492186 ALLURA XPER FD10 SYSTEM, X-RAY, ANGIOGRAPHIC IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown