BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 17498457 · Received August 10, 2023

    Report

    Report Number
    3003768277-2023-04361
    Event Type
    Malfunction
    Date Received
    August 10, 2023
    Date of Event
    July 27, 2023
    Report Date
    February 11, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838059085
    PMA / PMN Number
    K130638
    Removal / Correction Number
    3003768277-06/05/2023-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. A PHILIPS SERVICE ENGINEER INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT 4 LOOSE BOLTS WERE FOUND, AND A METAL STRIP IS MISSING. THE METAL STRIP PREVENTS PLAY BETWEEN THE METAL BLOCK AND THE LINEAR BEARING, AND ADDITIONAL SHEAR STRESS TO THE BOLTS. THE C-ARC IS CONNECTED TO THE METAL BLOCK. UPON SOME FUNCTIONAL TEST FSE ARRANGED A NEW METAL STRIP WAS. THE FSE INSTALLED THE METAL STRIP AND MOUNTED THE BOLTS WITH LOCTITE, AFTER INSTALLING THE FLEXARM METAL STRIP, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OCCURRED PRIOR TO COMPLETION OF THE FIELD CORRECTION 3003768277-06/05/2023-003-C, WHICH ADDRESSES THE CAUSES ASSOCIATED WITH THE REPORTED MALFUNCTION.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT THE ALLURA XPER FD20 OR TABLE SYSTEM FLEXMOVE TRANSVERSAL BEARING WAS LOOSE. THE SYSTEM WAS NOT IN CLINICAL USE AND NO HARM HAS BEEN REPORTED. UPON EVALUATION IT WAS DETERMINED THAT THE WRONG STRIP WAS ON THE FLEXMOVE COMPONENT. THE STRIP WAS REPLACED, AND THE SYSTEM WAS RETURNED TO FUNCTIONALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797635 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 OR TABLE 00884838059085

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown