BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD20/10 & ALLURA XPER FD20/20

    MDR report key: 16936561 · Received May 15, 2023

    Report

    Report Number
    3003768277-2023-02867
    Event Type
    Malfunction
    Date Received
    May 15, 2023
    Date of Event
    May 3, 2023
    Report Date
    June 10, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K033737
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 NOT IN CLINICAL USE WHEN THE ISSUE OCCURRED. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT FLEX PC MONITOR WAS NOT TURNING ON. REVIEW OF THE SYSTEM LOG FILE CONFIRMED THE REPORTED MALFUNCTION. DURING TROUBLESHOOTING, FSE FOUND THAT THE RGB MEDIA WALL¿S POWER SUPPLY WAS NOT STARTING PROPERLY. ONE OF THEM DID NOT TURN ON DESPITE THE CORRECT VOLTAGES AND THE OTHER WAS INTERMITTENT SINCE THERE WAS A FALSE CONTACT IN THE POWER. THIS ISSUE WAS RESOLVED BY SWITCHING ON/OFF THE SYSTEM AND BY VERIFICATION OF VIDEO, BUT THE RGB MEDIA WALL ISSUE REOCCURRED AGAIN, SO THE FSE REPLACED THE RGB MEDIA WALL. AFTER REPLACEMENT OF RGB MEDIA WALL, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME. HEALTH IMPACT CODE WAS CORRECTED.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE FLEXVISION MONITOR WOULD NOT TURN ON. THE ISSUE WAS FOUND DURING CLINICAL USE. 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
    1671257 ALLURA XPER FD20/10 & ALLURA XPER FD20/20 INTERVENTIONAL FLOUROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20/10 & FD20/20

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown