BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20

    MDR report key: 16467301 · Received March 2, 2023

    Report

    Report Number
    3003768277-2023-01152
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    February 11, 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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO ADDITIONAL INFORMATION COLLECTED, SYSTEM WAS OUTSIDE THE CLINICAL USE. THE PHILIPS SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE SYSTEM IS UNABLE TO START UP. FSE FOUND THAT CAUSE OF THE REPORTED ISSUE WAS SBS BOARD. FSE REPLACED THE SBC BOARD. AFTER REPLACEMENT OF SBC BOARD SYSTEM 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, SYSTEM WAS UNABLE TO START UP. SYSTEM WAS IN CLINICAL USE. NO HARM HAS BEEN REPORTED TO PHILIPS. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM AND CONFIRMED THE REPORTED PROBLEM. TROUBLESHOOTING ACTIONS SHOWED A PROBLEM WITH THE SBC BOARD. THE FSE REPLACED THE SBC BOARD AND DEVICE RETURNED TO FULL FUNCTIONALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454199 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