BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 17734621 · Received September 13, 2023

    Report

    Report Number
    3003768277-2023-04980
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    August 14, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054196
    PMA / PMN Number
    K161563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE INFORMATION COLLECTED, THE SYSTEM WAS OUTSIDE OF CLINICAL USE AT THE TIME OF THE EVENT. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THERE WAS A DISK SPACE ISSUE ON THE ALLURA XPER FD10/10 SYSTEM AND THEREFORE IT WOULD PREVENT IMAGE PROCESSING. REVIEW OF LOG FILE SHOWED THAT MALFUNCTIONING FRONTAL IP-PC. FSE REPLACED IPPC AND DATA DRIVES. AFTER REPLACEMENT THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE FAILURE ANALYSIS WAS EXECUTED HDD BAY/LABEL WAS REPLACED PER PRQ. BAY LIGHTS NEEDED THEIR INDIVIDUAL POWER BUTTONS PRESSED TO COME ON; ISSUE WAS RESOLVED AFTER THIS WAS DONE. CMOS BATTERY CHANGED DUE TO LOW CHARGE. FINAL TESTING COMPLETED AND PASSED. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THERE WAS A DISK SPACE ISSUE ON THE ALLURA XPER FD10/10 SYSTEM AND THEREFORE IT WOULD PREVENT IMAGE PROCESSING. NO HARM WAS REPORTED TO PHILIPS. A PHILIPS FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND REPLACED THE CLARITYIQ II IMAGE PROCESSING PC NO HDD AND THE HARD DISKS. THE DEVICE WAS RETURNED TO EXPECTED FUNCTIONALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676683 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 Unknown