BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 17797878 · Received September 22, 2023

    Report

    Report Number
    3003768277-2023-05260
    Event Type
    Malfunction
    Date Received
    September 22, 2023
    Date of Event
    September 11, 2023
    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
    TU
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 TURNING ON. ANALYSIS OF THE SYSTEM LOG FILE CONFIRMED THE MALFUNCTION. UPON TROUBLESHOOTING, FSE FOUND THE ISSUE WITH CABINET B OF MEDIAWALL UNIT. THE FSE REPLACED THE RGB MEDIAWALL 4200. AFTER REPLACEMENT OF THE RGB MEDIAWALL UNIT, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE SYSTEM DID NOT POWER ON SUCCESSFULLY. THE ISSUE WAS FOUND OUTSIDE OF CLINICAL USE. NO HARM HAS BEEN REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123427 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