BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 19755308 · Received July 16, 2024

    Report

    Report Number
    3003768277-2024-03883
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    July 2, 2024
    Report Date
    September 13, 2024
    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
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. AS PER INFORMATION COLLECTED, THE ISSUE OCCURRED DURING CARDIOVASCULAR DIAGNOSTIC AND TREATMENT PROCEDURE WITHOUT ANY IMPACT ON THE PROCEDURE. THE PHILIPS FIELD SERVICE ENGINEER(FSE) VISITED ONSITE AND CONFIRMED THE X-RAY SWITCH ON FOOT SWITCH WAS HAVING INTERMITTENT ISSUE. THE PHILIPS ENGINEER REPLACED WIRED FOOTSWITCH AND RETURNED TO PHILIPS FOR FURTHER ANALYSIS. THE ANALYSIS CONFIRMED MECHANICAL FAULT AND IDENTIFIED THAT BRACKET WAS LOOSE. FOLLOWING THE REPLACEMENT, 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 WAS REPORTED TO PHILIPS THAT THE DEVICE'S WIRED FOOTSWITCH WAS INTERMITTENTLY FAILING TO TRIGGER EXPOSURE AND CINE, WHICH CAN IMPACT IMAGING. 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
    722349 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