BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 17096643 · Received June 9, 2023

    Report

    Report Number
    3003768277-2023-03493
    Event Type
    Malfunction
    Date Received
    June 9, 2023
    Date of Event
    May 30, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085268
    PMA / PMN Number
    K163715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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 IN CLINICAL USE FOR TREATMENT WHEN THE ISSUE OCCURRED AND THE PATIENT'S SHOULDER WAS PULLED BACK BUT THE PATIENT WAS UNHARMED, AND NO INJURY OCCURRED TO THE PATIENT AND THE PROCEDURE WAS COMPLETED AS PLANNED. THE CUSTOMER REPORTED THAT THE C-ARM CABLE CAUGHT THE ARM BOARD ON ROTATION AND BROKE THE ARM BOARD. THE CUSTOMER ORDERED AND REPLACED THE ARM SUPPORT BOARD. AFTER REPLACEMENT OF THE ARM SUPPORT BOARD, 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 THE C-ARM BROKE RESULTING IN YANKING A PATIENT'S SHOULDER. ALSO THE ARM SUPPORT BOARD WAS BROKEN. THE PATIENT OUTCOME IS UNKNOWN AND IT IS UNKNOWN IF THERE WAS ACTUAL HARM TO THE PATIENT . PHILIPS IS COLLECTING ADDITIONAL INFORMATION. WE ARE CONSERVATIVELY REPORTING THIS EVENT AS AN INJURY WHILE THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452779 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20 00884838085268

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown