BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 16246322 · Received January 26, 2023

    Report

    Report Number
    3003768277-2023-00401
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    October 13, 2022
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838059061
    PMA / PMN Number
    K130638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE SYSTEM WAS IN CLINICAL USE WHEN THE ISSUE OCCURRED AND THE TREATMENT WAS COMPLETED AS PLANNED BY RESTARTING THE SYSTEM. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE CUSTOMER OBSERVED GREEN ARTEFACT IN THE MONITOR. THE FSE SUGGESTED THE CUSTOMER TO REPLACE RGB MEDIAWALL TO RESOLVE THE REPORTED ISSUE. THE FSE REPLACED RGB MEDIAWALL VIA ANOTHER CASE. AFTER REPLACEMENT OF THE RGB MEDIAWALL, 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 THAT THE FLEXVISION MONITOR HAD GREEN ARTIFACT AND SYSTEM WAS DOWN. 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
    792653 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 BIPLANE 00884838059061

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown