BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 19728603 · Received July 12, 2024

    Report

    Report Number
    3003768277-2024-03822
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    July 2, 2024
    Report Date
    September 6, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054196
    PMA / PMN Number
    K162859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 NOT IN CLINICAL USE WHEN THE ISSUE WAS IDENTIFIED. THE PHILIPS REMOTE SERVICE ENGINEER (RSE) ANALYZED THE SYSTEM REMOTELY AND CONFIRMED THAT SYSTEM DID NOT BOOTUP CORRECTLY. AFTER REVIEWING THE LOG FILE RSE FOUND THE FRONTAL & LATERAL IP-PC AND THE HOST NOT TURNING ON. TO RESOLVE THE ISSUE FIELD SERVICE ENGINEER (FSE) REAR PANEL IN THE POWER DISTRIBUTION UNIT IN THE M CABINET AND RECONFIGURING THE SD CARD FOR THE NEW GPDU ID. AFTER REPLACEMENT OF PD ASSAY, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CAUSE OF THE IP PC FAILURE DETERMINED BY THE SUPPLIER'S PART ANALYSIS DURING THE VISUAL INSPECTION, THE ENGINEER FOUND BENT ELEMENT FROM PD ASSAY REAR PANEL BOXED. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM DID NOT BOOTUP CORRECTLY. THE DEVICE WAS OUTSIDE OF CLINICAL USE AT THE TIME OF THE REPORTED EVENT. NO HARM WAS REPORTED TO PHILIPS.PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272237 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10/10 00884838054196

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown