BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 16564413 · Received March 17, 2023

    Report

    Report Number
    3003768277-2023-01730
    Event Type
    Malfunction
    Date Received
    March 17, 2023
    Date of Event
    November 2, 2022
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838099241
    PMA / PMN Number
    K200917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PHILIPS SERVICE ENGINEER CONFIRMED A RODENT PROBLEM AT THE SITE AND THAT A RODENT HAD DAMAGED A FIBER OPTIC CABLE AND THE HYBRID EXTENSION BOX (HEB). THE SERVICE ENGINEER REPLACED THE HEB. AFTER REPLACING THE HEB, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED TO PHILIPS THAT AZURION C-ARM MOVEMENT WAS NOT HAPPENING. PHILIPS HAS INVESTIGATED THIS COMPLAINT. IT IS UNKNOWN IF THE SYSTEM WAS IN CLINICAL USE WHEN THIS OCCURRED. THE CUSTOMER DID NOT PROVIDE DETAILS REGARDING CLINICAL USE, HOWEVER, THERE WAS NO REPORT OF ANY PATIENT IMPACT OR HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664741 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M12 00884838099241

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown