BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 16522252 · Received March 10, 2023

    Report

    Report Number
    3003768277-2023-01360
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    February 18, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054189
    PMA / PMN Number
    K161563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE MOTORIZED MOMENT WAS PARTIALLY AVAILABLE. UPON FUNCTIONAL TESTING, THE FSE IDENTIFIED THERE IS A MALFUNCTION ON HYBRID EXTENSION BOX (HEB) POWER SUPPLY. HEB NEEDS REPLACEMENT AS THE FUSE CONNECTED TO HEB IS BLOWING CONTINUOUSLY. TO RESOLVE THIS ISSUE, FSE REPLACED THE FUSE CONNECTED TO HEB. AFTER REPLACEMENT OF FUSE 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 MOTORIZED MOVEMENT WAS PARTIALLY UNAVAILABLE. THE SYSTEM WAS IN CLINICAL USE. NO HARM HAS BEEN REPORTED TO PHILIPS. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE MOVEMENT WAS NOT POSSIBLE. TROUBLESHOOTING ACTIONS SHOWED A PROBLEM WITH THE HYBRID EXTENSION BOX. THE FSE REPLACED THE HYBRID EXTENSION BOX AND RETURNED THE SYSTEM TO USE IN GOOD WORKING ORDER. PHILIPS HAS STARTED AN INVESTIGATION FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1196353 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD10 00884838054189

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown