BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20

    MDR report key: 18334048 · Received December 15, 2023

    Report

    Report Number
    3003768277-2023-06983
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    November 23, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K033737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE DEVICE WAS NOT CLINICAL USE, WHEN THE ISSUE OCCURRED. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE SYSTEM WAS NOT BOOTING UP. ANALYSIS OF THE SYSTEM LOG FILE DOES NOT SHOW ANY SYSTEM BOOT UP MALFUNCTION. DURING TROUBLESHOOTING, THE FSE FOUND THAT THE SYSTEM WAS STUCK IN THE BIOS SCREEN WITH DISK BOOT ERROR ALONG WITH SINGLE BOARD COMPUTER (SBC). THE FSE REPLACED THE SBC AND WAS ABLE TO BOOT UP. AFTER RESETTING, IT WAS IDENTIFIED THAT THE ISSUE AGAIN OCCURRED WITH THE DEAD CMOS BATTERY ON THE NEW SBC, WHERE THE VOLTAGE WAS LESS THAN 1V. THE FSE REPLACED THE CMOS BATTERY ON THE NEW SBC AND PERFORMED SEVERAL REBOOTS. THE CAUSE OF THE SINGLE BOARD COMPUTER FAILURE COULD NOT BE CONCLUSIVELY DETERMINED BY THE SUPPLIER'S PART ANALYSIS; HOWEVER, THE REPLACEMENT OF THE SBC BY THE FIELD SERVICE ENGINEER HAS RESOLVED THE REPORTED ISSUE AND RESTORED THE FUNCTIONALITY OF THE SYSTEM. AFTER REPLACEMENT OF THE SBC AND CMOS BATTERY, 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 WAS REPORTED TO PHILIPS THAT THE ALLURA DEVICE WOULD NOT BOOT UP. 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
    2268366 ALLURA XPER FD20 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM. OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown