BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 11699960 · Received April 21, 2021

    Report

    Report Number
    3003768277-2021-10012
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    February 25, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838059054
    PMA / PMN Number
    K033737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE INFORMATION COLLECTED, THE ONGOING DIAGNOSTIC PROCEDURE WAS NOT IMPACTED AND WAS COMPLETED AS PLANNED. PHILIPS HAS CONFIRMED THAT THE L-ARM ROTATION COVER BECAME DETACHED AND FELL ON THE FLOOR. BASED ON AVAILABLE INFORMATION, THE COVER MOST LIKELY DETACHED AFTER A COLLISION. A PHILIPS SERVICE ENGINEER RESEATED THE L-ARM COVER AND THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO PHILIPS THAT THE L-ARM ROTATION COVER CAME LOOSE. NO HARM TO THE PATIENT HAS BEEN REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597860 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