BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZURION

    MDR report key: 19585097 · Received June 21, 2024

    Report

    Report Number
    3003768277-2024-03438
    Event Type
    Injury
    Date Received
    June 21, 2024
    Date of Event
    June 5, 2024
    Report Date
    March 5, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099258
    PMA / PMN Number
    K200917
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION RECEIVED, THE ISSUE OCCURRED WHILE THE PATIENT WAS BEING TRANSFERRED TO THE OPERATING TABLE AND WAS ADJUSTING TO A MORE COMFORTABLE POSITION. THE CUSTOMER WAS USING A NEURO MATTRESS WITH A NEURO TABLE, AND HAD POSITIONED THE MATTRESS ABOVE THE TABLE'S HEAD, WHICH CAUSED THE MATTRESS TO NOT BE FULLY SUPPORTED BY THE TABLE. THE PATIENT FELL FROM THE TABLE WITH THE MATTRESS WHEN SHE PROPPED HERSELF UP ON THE LEFT SIDE OF THE MATTRESS, WHERE THE MATTRESS WAS NOT FULLY SUPPORTED BY THE TABLE. THE MATTRESS'S NARROWEST END IS INTENDED TO COVER THE 440 MM SECTION OF THE TABLETOP (AT SHOULDER POSITION) AND IT IS NOT INTENDED TO BE PLACED ON THE NARROWEST PART OF THE TABLE (190 MM), WHICH IS RESERVED FOR THE HEAD SUPPORT/NEURO WEDGE. THE MATTRESS WAS INCORRECTLY POSITIONED DURING THE TRANSFER. THE MATTRESS IS DESIGNED SO THAT IT IS NOT FIXED TO THE TABLETOP TO ALLOW REPOSITIONING OF THE MATTRESS ON THE TABLETOP AND TO NOT COMPROMISE IMAGE QUALITY AND CLEANABILITY OF THE MATTRESS AND TABLETOP. THE CODES HAVE BEEN UPDATED PER THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT ON (B)(6) 2024, AT THE BEGINNING OF A SCHEDULED CORONARY ANGIOGRAPHY PROCEDURE, THE PATIENT FELL FROM THE TABLE. A COMPUTED TOMOGRAPHY SCAN (CT) SHOWED SPLENIC BLEEDING FOR WHICH THE PATIENT WAS SURGICALLY TREATED. THE PATIENT WAS KEPT FOR MONITORING, RECOVERED AND HAS BEEN DISCHARGED FROM THE HOSPITAL. THE PLANNED CORONARY ANGIOGRAPHY WAS NOT COMPLETED BEFORE THE DISCHARGE. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1197872 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20 00884838099258

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention