BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 19803879 · Received July 23, 2024

    Report

    Report Number
    3003768277-2024-03979
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    July 1, 2024
    Report Date
    August 27, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054226
    PMA / PMN Number
    K162859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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 BOOTING UP. UPON FUNCTIONAL TESTING, THE FSE FOUND THAT THE POWER SUPPLY (DCPS) IN M-CABINET WAS DEFECTIVE, CAUSING THE SYSTEM TO NOT BOOT UP CORRECTLY. THE DEFECTIVE POWER SUPPLY WAS RETURNED FOR ANALYSIS, AND IT CONFIRMED BENT ELEMENTS FROM PARTS AND ELECTRONIC DEFECTS. TO RESOLVE THE REPORTED ISSUE, THE FSE REPLACED THE POWER SUPPLY (DCPS) IN M-CABINET. AFTER REPLACEMENT, THE SYSTEM RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM FAILED TO BOOT UP, IT WAS STUCK AT 00:00. THE DEVICE WAS NOT 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
    2484399 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20/20 00884838054226

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown