BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 19880703 · Received August 1, 2024

    Report

    Report Number
    3003768277-2024-04174
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    July 22, 2024
    Report Date
    December 26, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K200917
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION ACQUIRED THE SYSTEM WAS OUTSIDE OF CLINICAL USE AT THE TIME OF THE REPORTED EVENT. A PHILIPS REMOTE SERVICE ENGINEER (RSE) INSPECTED THE SYSTEM REMOTELY AND IDENTIFIED THE FUSE F1 IN THE POWER DISTRIBUTION UNIT (PDU) FANTRAY WAS DEFECTIVE. THE FUSE F1 WAS REPLACED; HOWEVER, THE ISSUE WAS NOT RESOLVED. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ON-SITE AND IDENTIFIED PDU FANTRAY AND DIRECT CURRENT POWER SUPPLY (DCPS) BOARD DID NOT HAVE VOLTAGE. THE FSE REPLACED THE PDU FANTRAY AND DCPS TO RESOLVE THE ISSUE. ADDITIONALLY, THE PDU CONTROL MODULE WAS ALSO REPLACED AS A PROACTIVE MEASURE. AFTER THE REPLACEMENT, THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER. THE PDU FANTRAY DCPS AND PDU CONTROL MODULE WERE RETURNED TO PHILIPS FOR FURTHER ANALYSIS. THE FUNCTIONAL TESTING OF PDU FANTRAY IDENTIFIED THAT POWER SUPPLY UNIT (PSU)01 AND PSU02 WERE DEFECTIVE. THE FUNCTIONAL TESTING OF THE PDU CONTROL MODULE PASSED, AND NO FAILURES WERE FOUND. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM DOES NOT START UP. NO HARM WAS REPORTED TO PHILIPS. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188311 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 5 M12

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown