BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 15833515 · Received November 21, 2022

    Report

    Report Number
    3003768277-2022-01106
    Event Type
    Malfunction
    Date Received
    November 21, 2022
    Date of Event
    October 28, 2022
    Report Date
    September 10, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054202
    PMA / PMN Number
    K161563
    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 THE ADDITIONAL INFORMATION COLLECTED, THE SYSTEM WAS IN CLINICAL USE WHEN THE ISSUE OCCURRED, AND THE SURGICAL TREATMENT WAS NOT AFFECTED. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT UNABLE TO USE DSA BUTTONS AND THE RACKS COULD NOT BE ROTATED. THE REPORTED ISSUE WAS SOLVED BY THE HOSPITAL ENGINEER, AFTER THAT 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 AN EMERGENCY CALL WAS MADE IN THE INTERVENTION ROOM FOR A PATIENT WITH CHEST PAIN WHO NEEDED INTERVENTIONAL TREATMENT. DURING THE PREOPERATIVE PREPARATION, THE TECHNICIAN FOUND THAT SOME DSA BUTTONS COULD NOT BE USED AND THE RACK COULD NOT BE ROTATED. THERE WAS A TREATMENT IN DELAY BUT NO HARM HAS BEEN REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1797937 ALLURA XPER FD INTEVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 00884838054202

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown