BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 15974138 · Received December 13, 2022

    Report

    Report Number
    3003768277-2022-01521
    Event Type
    Malfunction
    Date Received
    December 13, 2022
    Date of Event
    November 8, 2022
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWV
    UDI-DI
    00884838059054
    PMA / PMN Number
    K130638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE SYSTEM WAS NOT ABLE TO EXPOSE. UPON INSPECTION, FSE DETERMINED THAT THE DETECTOR WAS FAULTY. THE FSE REPLACED THE IMAGING DETECTOR AND RAN ALL CALIBRATIONS. AFTER REPLACEMENT OF IMAGING DETECTOR, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THEY WERE UNABLE TO EXPOSE AND IMAGING WAS UNAVAILABLE. THE ISSUE WAS FOUND DURING CLINICAL USE. NO HARM HAS BEEN REPORTED TO PHILIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456742 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWV PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 00884838059054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown