BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD10

    MDR report key: 17223828 · Received June 29, 2023

    Report

    Report Number
    3003768277-2023-03855
    Event Type
    Malfunction
    Date Received
    June 29, 2023
    Date of Event
    June 19, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K041949
    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. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT SYSTEM CANNOT BOOT UP. UPON DID SOME FUNCTIONAL TEST FSE CONFIRMED THAT THAT THE SBC WAS DEFECTIVE. THE FSE REPLACED THE SBC BOARD AND INSTALLED THE SYSTEM SOFTWARE. AFTER REPLACING THE SBC BOARD, 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 HAS BEEN REPORTED TO PHILIPS THAT THE SYSTEM WOULD NOT START. THE ALLURA SYSTEM WAS NOT IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. NO HARM TO USER OR PATIENT WAS REPORTED. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND VERIFIED AN ISSUE WITH THE SBC (SINGLE BOARD COMPUTER). FSE REPLACED THE SBC AND RETURNED THE SYSTEM TO USE IN GOOD WORKING CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265477 ALLURA XPER FD10 INTERVENTIONAL FLOUROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown