BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20

    MDR report key: 20821107 · Received December 2, 2024

    Report

    Report Number
    3003768277-2024-006965
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    November 8, 2024
    Report Date
    December 30, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K033737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. A PHILIPS ENGINEER RECEIVED THAT NEED TO RECREATE THE IMAGE STORE. UPON CHECKING WITH CUSTOMER, QUOTE FOR EVALUATION AND REPAIR SERVICE WAS SENT TO CUSTOMER HOWEVER EOL/EOS DATE EXPIRED. NO SERVICE HAS BEEN PERFORMED BY PHILIPS. TO DATE, NO FURTHER INFORMATION WAS RECEIVED. THE CODES WERE UPDATED BASED ON INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM'S IMAGE STORE NEEDED TO BE RECREATED, WHICH CAN IMPACT IMAGING. NO HARM WAS REPORTED TO PHILIPS. WE ARE CONSERVATIVELY REPORTING THIS EVENT AS THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304944 ALLURA XPER FD20 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown