BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 20383511 · Received October 7, 2024

    Report

    Report Number
    3003768277-2024-05716
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    September 16, 2024
    Report Date
    January 21, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838059030
    PMA / PMN Number
    K130638
    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 THE COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, CUSTOMER WAS PERFORMING DIAGNOSTIC PROCEDURE AND COMPLETED AS PLANNED BY USING ANOTHER LAB. PHILLIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT C-ARM ROTATION MOVEMENT FAILED. REVIEW OF THE SYSTEM LOG FILE SHOWED THAT THERE WAS AN ERROR IN UPON TROUBLESHOOTING, FSE FOUND THAT THERE WAS AN ERROR IN Z-ROTATION AND THE Z ROTATION MOTOR WAS LEAKING OIL. TO RESOLVE THIS ISSUE, FSE REPAIRED BROKEN WIRE ON Z-ROTATION POT, REPLACED Z-ROTATION MOTOR, CALIBRATED Z-ROTATION MOVEMENTS. AFTER THAT, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON INVESTIGATION OUTCOME. EVALUATION METHOD CODE WAS CORRECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE C-ARM ROTATIONAL MOVEMENT FAILED. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216647 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10 00884838059030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown