BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 20427876 · Received October 11, 2024

    Report

    Report Number
    3003768277-2024-05780
    Event Type
    Malfunction
    Date Received
    October 11, 2024
    Date of Event
    October 1, 2024
    Report Date
    May 10, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    IZI
    UDI-DI
    00884838059085
    PMA / PMN Number
    K130842
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. A PHILIPS REMOTE SERVICE ENGINEER (RSE) EVALUATED THE SYSTEM REMOTELY AND CONFIRMED THE REPORTED PROBLEM. ANALYSIS OF LOG FILE REVEALED AN APPLICATION ERROR RELATED TO A DEFECT IN COOLING UNIT, WHICH LED TO AN ERROR IN TUBE ANODE. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND IDENTIFIED OIL LEAKAGE FROM THE COOLING UNIT INTO A SPILL TRAY. TO RESOLVE THE REPORTED ISSUE, THE COOLING UNIT WAS REPLACED. THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER AND READY FOR CLINICAL USE. THE COOLING UNIT WAS RETURNED FOR FURTHER ANALYSIS. TESTING CONFIRMED A LEAKAGE AT THE HOSE OF THE COOLING UNIT. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE ERRORS INDICATING THE FLUOROSCOPY DOSE WAS REDUCED, RESULTING IN ARTIFACTS THAT NECESSITATED MOVING THE PATIENT TO ANOTHER ROOM TO COMPLETE THE PROCEDURE. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM TO THE PATIENT OR USER WAS REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345865 ALLURA XPER FD SYSTEM, X-RAY, ANGIOGRAPHIC IZI PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 OR TABLE 00884838059085

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown