BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 21504591 · Received March 3, 2025

    Report

    Report Number
    3003768277-2025-002168
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    February 14, 2025
    Report Date
    March 14, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054202
    PMA / PMN Number
    K162859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT, ALTHOUGH THE ISSUE OCCURRED WHILE THE SYSTEM WAS IN CLINICAL USE, THE PROCEDURE WAS NOT IMPACTED AND WAS COMPLETED AS PLANNED. NO HARM OR INJURY WAS REPORTED TO PHILIPS. A PHILIPS REMOTE SERVICE ENGINEER (RSE) CONNECTED WITH THE CUSTOMER AND PERFORMED REMOTE TROUBLESHOOTING ON THE SYSTEM. TROUBLESHOOTING CONFIRMED THE ERROR MESSAGE "IXR-PRO-FILAMENT-CURRENT-OUT-OF-RANGE (1.0)". PHILIPS PROVIDED A QUOTE TO THE CUSTOMER FOR ONSITE SERVICE AND X-RAY TUBE REPLACEMENT, BUT THE CUSTOMER DID NOT APPROVE THE QUOTE; NO DEVICE REPAIR OR REPLACEMENT WAS PERFORMED BY PHILIPS. NO FURTHER INFORMATION COULD BE OBTAINED FROM THE CUSTOMER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM GAVE AN ALERT INDICATING X-RAYS WERE NOT POSSIBLE. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF REPORTED EVENT. 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
    1330719 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 00884838054202

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown