BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20

    MDR report key: 17296993 · Received July 11, 2023

    Report

    Report Number
    3003768277-2023-03987
    Event Type
    Malfunction
    Date Received
    July 11, 2023
    Date of Event
    June 14, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K033737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. PHILIPS FIELD SERVICE ENGINEER FSE VISITED ONSITE FOR PERFORMING THE TROUBLESHOOTING OF THE REPORTED PROBLEM. FSE PERFORMED DIAGNOSTICS, INSPECTED LOGFILES, FOLLOWED FFT, AND DETERMINED THAT SPP IN FRONTAL STAND NEEDS TO BE REPLACED. PROVIDED APM QUOTE TO CUSTOMER. FSE UNSURE ABOUT WHETHER A PROCEDURE BEING PERFORMED OR NOT. NO SERVICE HAS BEEN PERFORMED BY PHILIPS SINCE THE CALL RECEIVED FROM THE THIRD-PARTY COMPANY, NOT THE ACTUAL HOSPITAL. TO DATE, THERE HAVE BEEN NO FURTHER REPORTS OF THIS ISSUE. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE FRONTAL ARM DID NOT HAVE POWER, MOTOR OR BRAKE FUNCTIONALITY. THE SYSTEM WAS IN CLINICAL USE. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1569260 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