BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 16974731 · Received May 22, 2023

    Report

    Report Number
    3003768277-2023-02956
    Event Type
    Malfunction
    Date Received
    May 22, 2023
    Date of Event
    October 12, 2022
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838059061
    PMA / PMN Number
    K130638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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 LOW LOAD FLUORO ONLY AVAILABLE AND TEAL UNIT OF THE SYSTEM WENT OFFLINE. UPON TROUBLESHOOTING UTS CIRCUITRY AND GSSPDU, FSE FOUND VOLTAGE SENSOR REPORTING ERROR, F4 FUSE BLOWN IN UTS AND PCM SP1 BOARD BURNT. THE FSE FOUND TEAL POWER UNIT FAILURE. THE FSE REPLACED THE POWER DISTRIBUTION UNIT (PDU). AFTER REPLACEMENT OF PDU, 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 WAS GIVING AN ERROR OF ¿LOW LOAD FLUORO ONLY AVAILABLE¿. THE SYSTEM WAS IN CLINICAL USE. THERE WAS NO REPORTED PATIENT OR USER HARM. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THE REPORTED PROBLEM. TROUBLESHOOTING ACTIONS SHOWED A PROBLEM WITH A BLOWN FUSE IN THE POWER DISTRIBUTION UNIT (PDU). THE FSE REPLACED THE PDU AND RETURNED THE SYSTEM TO USE IN GOOD WORKING ORDER. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN FURTHER INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760716 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 BIPLANE 00884838059061

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown