BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 16665181 · Received April 3, 2023

    Report

    Report Number
    3003768277-2023-02103
    Event Type
    Malfunction
    Date Received
    April 3, 2023
    Date of Event
    March 21, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838059054
    PMA / PMN Number
    K130638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 DEVICE IS UNABLE TO PERFORM FLUOROSCOPY AND EXPOSURE. UPON FURTHER INSPECTION, THE FSE FOUND THAT THE PROBLEM WITH FDC. THE FSE REPLACED THE FDC. AFTER REPLACEMENT FDC, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT EXPOSURE WAS NOT POSSIBLE. THE SYSTEM WAS IN CLINICAL USE. NO HARM HAS BEEN REPORTED TO PHILIPS. A PHILIPS SERVICE ENGINEER INSPECTED THE SYSTEM ON SITE. IT WAS IDENTIFIED THAT FDC (DETECTOR CONTROLLER) WAS FAILING. THE FDC HAS BEEN REPLACED THAT THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1265615 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 00884838059054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown