BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 18352506 · Received December 18, 2023

    Report

    Report Number
    3003768277-2023-07018
    Event Type
    Malfunction
    Date Received
    December 18, 2023
    Date of Event
    November 29, 2023
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085350
    PMA / PMN Number
    K172822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. PHILIPS REMOTE SERVICE ENGINEER (RSE) CONNECTED WITH THE CUSTOMER AND CONFIRMED THE REPORTED ISSUE. REVIEW OF SYSTEM LOG FILES SHOWS INCOMPLETE STARTUP GROUP AND MISSING MACHINES: X-RAY-PC. UPON REMOTE ANALYSIS, RSE FOUND THAT FIP DEP155665 POINTS TO THE XRAY PC BEING THE ISSUE. THE PHILIPS ENGINEER ASKED THE CUSTOMER TO REPLACE THE XRAY PC. NO FURTHER ACTION WAS DONE FROM PHILIPS END. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME. EVALUATION METHOD CODE WAS CORRECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE SYSTEM CRASHED AND WOULD NOT BOOT UP COMPLETELY. THE SYSTEM WAS NOT IN CLINICAL USE. NO USER OR PATIENT HARM HAS BEEN REPORTED. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2267904 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM. OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 B12 00884838085350

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown