BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 17668873 · Received September 1, 2023

    Report

    Report Number
    3003768277-2023-04756
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Date of Event
    August 2, 2023
    Report Date
    February 11, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838059054
    PMA / PMN Number
    K130638
    Removal / Correction Number
    3003768277-06/05/2023-00
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 THE REPORTED PROBLEM THE FSE EXAMINED THE SYSTEM AND DETERMINED THAT ONE SIDE COUPLING BLOCK HOLES ARE SMALLER THAN THE ACTUAL (HOLES M5 SHOULD BE M6). AS A PART OF REPAIR ACTIVITY, THE FSE REPLACED COUPLING BLOCK KIT. AFTER THAT, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME. THE DEVICE PROBLEM CODE, EVALUATION METHOD CODES WERE CORRECTED.

    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 EQUIPMENT WAS DOWN DUE TO ISSUE WITH THE TRANSVERSAL GUIDE OF THE FLEXMOVE. THE SYSTEM WAS NOT IN CLINICAL USE AT THE TIME OF THE EVENT. NO HARM HAS BEEN REPORTED TO PHILIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263309 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 00884838059054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown