BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20

    MDR report key: 17278077 · Received July 7, 2023

    Report

    Report Number
    3003768277-2023-03976
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 27, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K033737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    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 NOT STARTING. DURING TROUBLESHOOTING, THE FSE FOUND THAT THE THAT THE PC BOARD SBC AND THE MAIN POWER SUPPLY WERE DEFECTIVE. THE FSE REPLACED THE PC BOARD SBC AND THE POWER SUPPLY. THE DEFECTIVE SINGLE BOARD COMPUTER (SBC) WAS RETURNED TO PHILIPS FOR FURTHER ANALYSIS. THE ANALYSIS CONFIRMED THE MALFUNCTION OF THE SBC AND IDENTIFIED THAT THE FAILURE WAS DUE TO A BROKEN PART. FOLLOWING THE REPLACEMENT OF THE SBC AND POWER SUPPLY, 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 ALLURA SYSTEM WAS NOT STARTING UP. THE SYSTEM WAS NOT IN CLINICAL USE. NO HARM HAS BEEN REPORTED TO PHILIPS. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND REPLACED THE POWERTRAY AND THE SINGLE BOARD COMPUTER AND RETURNED THE SYSTEM TO USE IN GOOD WORKING ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421333 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