BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 17116505 · Received June 13, 2023

    Report

    Report Number
    3003768277-2023-03568
    Event Type
    Malfunction
    Date Received
    June 13, 2023
    Date of Event
    May 16, 2023
    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
    NH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE SYSTEM WAS NOT IN CLINICAL USE. THE PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT LIGHTS WERE NOT TURNING ON INTERMITTENTLY WHEN WIRED FOOTSWITCH WAS BEING PRESSED. UPON FUNCTIONAL TESTING, FSE FOUND THAT THE CONNECTION THAT INTAKES TWO WIRES COMING IN FROM THE HOSPITAL WAS NOT WORKING ON THE BOARD. TO RESOLVE THIS ISSUE, FSE REPLACED INPUT/OUTPUT (IO) RELAY BOARD. AFTER REPLACEMENT OF IO RELAY BOARD, 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 USER WAS UNABLE TO PERFORM FLUORO AND BELIEVE IT'S AN ISSUE WITH THE FOOT SWITCH. NO HARM WAS REPORTED. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND IDENTIFIED AN ISSUE WITH THE PIO RELAY BOARD. FSE REPLACED THE PIO RELAY BOARD AND NOW THE SYSTEM IS IN GOOD WORKING CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213697 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 Unknown