BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20

    MDR report key: 18208394 · Received November 27, 2023

    Report

    Report Number
    3003768277-2023-06522
    Event Type
    Malfunction
    Date Received
    November 27, 2023
    Date of Event
    November 13, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K033737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO ADDITIONAL INFORMATION COLLECTED THE DEVICE WAS IN CLINICAL USE AT TIME OF EVENT AND THE PROCEDURE WAS COMPLETED BY RESTART OF THE SYSTEM. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE SYSTEM WAS UNABLE TO START UP. UPON FUNCTIONAL TESTING FSE FOUND THE SBC HAD INTERMITTENT ISSUE. FSE RE-PLUGGED THE SBC, BUT ISSUE PERSIST. UPON FURTHER ANALYSIS FSE IDENTIFIED THAT DISK WAS DEFECTIVE. TO RESOLVE THE ISSUE FSE REPLACED THE DISK AND REINSTALL THE SYSTEM, BUT THE ISSUE PERSIST AND LATER FSE CONFIRMED THAT DEFECTIVE SIB WAS ACTUAL CAUSE OF THE PROBLEM. TO RESOLVE THE PROBLEM FSE REPLACED THE SIB. AFTER REPLACEMENT OF DISK AND SIB, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM WOULD NOT STARTUP AT 00:00. THE SYSTEM WAS NOT IN CLINICAL USE. NO USER OR PATIENT HARM HAS BEEN REPORTED. PHILIPS HAS STARTED AN INVESTIGATION REGARDING THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239311 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 Unknown