BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20

    MDR report key: 19857085 · Received July 29, 2024

    Report

    Report Number
    3003768277-2024-04084
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    July 21, 2024
    Report Date
    October 16, 2024
    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. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE SYSTEM WAS UNABLE TO START UP. UPON FUNCTIONAL TESTING, THE FSE FOUND THAT THE SINGLE BOARD COMPUTER (SBC) DIDN'T START UP DUE TO RANDOM ACCESS MEMORY (RAM) ON SBC DIDN'T CONTACT WELL AND RE-PLUGGING THE RAM ON SBC DID NOT RESOLVE THE ISSUE. TO RESOLVE THE REPORTED ISSUE, THE FSE REPLACED THE SINGLE BOARD COMPUTER (SBC). AFTER REPLACEMENT, 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 DID NOT BOOT UP. THE SYSTEM WAS NOT IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. THERE WAS NO REPORTED PATIENT OR USER HARM. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214909 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