BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AZURION

    MDR report key: 19983369 · Received August 14, 2024

    Report

    Report Number
    3003768277-2024-04423
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    July 26, 2024
    Report Date
    November 13, 2024
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085367
    PMA / PMN Number
    K172822
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO ADDITIONAL INFORMATION COLLECTED, THE SYSTEM WAS NOT IN CLINICAL USE WHEN THE ISSUE WAS IDENTIFIED. THE PHILIPS FIELD SERVICE ENGINEER (FSE) EXAMINED THE SYSTEM ONSITE AND CONFIRMED THAT THE EQUIPMENT SHUT DOWN. UPON TROUBLESHOOTING, THE PHILIPS FIELD SERVICE ENGINEER (FSE) CHECKED THE SYSTEM ONSITE AND CONFIRMED THE ENGINEER MADE A SUPERVISION AND FOUND THE POWER DISTRIBUTION UNIT (PDU) WAS DEFECTIVE. THE FSE DETERMINED THAT SPARE PARTS REQUESTED REMOTELY WERE CANCELLED, BECAUSE THEY DID NOT SOLVE A FAULT IN A PDU THAT HAS ALREADY BEEN UNINSTALLED, EQUIPMENT WORKING WITH A PDU ON LOAN AND WAITING FOR A PDU ACQUIRED THROUGH COMMERCIAL. TO RESOLVE THE ISSUE, FSE REPLACED PDU WITH A LOANER WHILE THE NEW ONE ARRIVES AND LATER LOANED PDU WAS REPLACED BY A PERMANENT PDU. AFTER REPLACEMENT, THE SYSTEM 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 SYSTEM SHUT DOWN. THE SYSTEM WAS IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. THERE WAS NO REPORTED PATIENT OR USER HARM. DUE TO THE LACK OF INFORMATION, WE ARE CONSERVATIVELY REPORTING THIS EVENT. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560960 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 B20 00884838085367

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown