BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AZURION

    MDR report key: 19930408 · Received August 7, 2024

    Report

    Report Number
    3003768277-2024-04264
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    July 25, 2024
    Report Date
    March 4, 2026
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838085268
    PMA / PMN Number
    K163715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. LOG ANALYSIS SHOWED THAT XPERCT FUNCTIONALITY STOPPED AT APPROXIMATELY 14:50 AND WAS RESTORED AT APPROXIMATELY 17:00, DURING WHICH TIME THE PROCEDURE CONTINUED, AND FLUOROSCOPY REMAINED AVAILABLE AND IN USE. WHEN HUMIDITY DECREASED TO 65%, XPERCT BECAME AVAILABLE AGAIN. A SUBSEQUENT XPERCT SCAN REVEALED A SEVERE CEREBRAL HEMORRHAGE REQUIRING EMERGENCY SURGICAL DRAINAGE. THE HOSPITAL HAS DECLINED TO PROVIDE ADDITIONAL CLINICAL INFORMATION. ENVIRONMENTAL READINGS TAKEN ONSITE INDICATED ELEVATED RELATIVE HUMIDITY AND LIMITED DEHUMIDIFICATION CAPACITY, WITH A SINGLE DEHUMIDIFIER SERVING TWO ROOMS. THE OPERATOR ROOM WAS REPORTED TO BE OUT OF HUMIDITY TOLERANCE, AND, ALTHOUGH REPORTED, NO BODYGUARD RECALIBRATION EVENTS WERE CAPTURED IN THE SYSTEM LOGS. XPERCT IS AN ADVANCED ROTATIONAL IMAGING SOFTWARE OPTION USED FOR 3D VISUALIZATION DURING INTERVENTIONAL PROCEDURES WHICH REQUIRES FAST, UNINTERRUPTED C-ARM ROTATION. REVIEW OF SYSTEM LOGS IDENTIFIED MULTIPLE TUBE COLLISION DETECTIONS AND ROTATION END POSITION FAILURES CONSISTENT WITH BODYGUARD STOPS TRIGGERED BY FLUCTUATING ENVIRONMENTAL CONDITIONS. RAPID ENVIRONMENTAL CHANGES AND TEMPERATURE DIFFERENTIALS CAN PROMOTE CONDENSATION ON SYSTEM COMPONENTS. CONDENSATION ON THE BODYGUARD COVER CAN CAUSE FALSE PROXIMITY READINGS, WHICH IS CONSISTENT WITH THE OBSERVED PATTERN. OPERATION UNDER CONDENSING CONDITIONS IS OUTSIDE THE ENVIRONMENTAL REQUIREMENTS FOR THE SYSTEM. PHILIPS ADVISED THE HOSPITAL TO STABILIZE ENVIRONMENTAL CONDITIONS, ENSURE CONTINUOUS CLIMATE CONTROL, AVOID RAPID HUMIDITY FLUCTUATIONS, AND IMPLEMENT DEDICATED DEHUMIDIFICATION. THE SITE SUBSEQUENTLY ADDED AN ADDITIONAL DEHUMIDIFIER, AND NO RECURRENCE HAS BEEN REPORTED. BASED ON ALL AVAILABLE INFORMATION, PHILIPS CONCLUDES THAT THE SYSTEM WAS LIKELY USED UNDER ENVIRONMENTAL CONDITIONS OUTSIDE THE NON-CONDENSING REQUIREMENT. NO SYSTEM MALFUNCTION WAS IDENTIFIED, AND SYSTEM PERFORMANCE RETURNED TO NORMAL ONCE ENVIRONMENTAL CONDITIONS STABILIZED. CORRECTION: THE FDA ESTABLISHMENT REGISTRATION NUMBER [FEI] HAS BEEN UPDATED AND REPORTED TO THE FDA, CHANGING FROM 3003768277 TO 3042175844, EFFECTIVE DECEMBER 21, 2025. THIS CHANGE REFLECTS AS ADMINISTRATIVE REGISTRATION UPDATE ONLY. THERE HAVE BEEN NO CHANGES TO THE REGISTERED OWNER/OPERATOR, OFFICIAL CORRESPONDENT, LEGAL ENTITY NAME, PHYSICAL ESTABLISHMENT ADDRESS, MANUFACTURING PROCESSES, OR TO THE DESIGN, SPECIFICATIONS, INTENDED USE, OR MANUFACTURING PROCESSES OF ANY LISTED DEVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT DURING A CEREBRAL PROCEDURE, THE XPER CT DID NOT FUNCTION AS INTENDED, PREVENTING THE PERFORMANCE OF A CROSS-SECTIONAL CT (COMPUTED TOMOGRAPHY SCAN). THE REPORT INDICATED THAT THIS LED TO A DELAY IN THE DIAGNOSIS OF A CEREBRAL HEMORRHAGE, NECESSITATING AN EMERGENCY SURGERY FOR DRAINAGE. THE PROCEDURE WAS TERMINATED, AND THE PATIENT WAS THEN TAKEN TO ANOTHER OPERATING SUITE FOR THE SURGERY. IT WAS NOTED THAT THE SURGERY CONCLUDED WITH A POSITIVE OUTCOME. AN INVESTIGATION INTO THIS COMPLAINT HAS BEEN INITIATED BY PHILIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183391 AZURION INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. AZURION 7 M20 00884838085268

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention