BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 11640678 · Received April 9, 2021

    Report

    Report Number
    3003768277-2021-10006
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Date of Event
    March 28, 2021
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838059054
    PMA / PMN Number
    K130638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE INFORMATION COLLECTED, THE CUSTOMER INDICATED THAT IT WAS NOT POSSIBLE TO DO FLUOROSCOPY, EXPOSURE AND MOVE THE TABLE. THE SYSTEM WAS RESTARTED SEVERAL TIMES, BUT RESTARTS WERE UNSUCCESSFUL. PHILIPS HAS ANALYZED THE LOG FILE AND NO PROBLEM HAS BEEN IDENTIFIED WITH THE AVAILABILITY OF FLUOROSCOPY AND EXPOSURE. THE LOG FILE SHOWED AN UNUSUAL PATTERN WITH ENABLING AND DISABLING OF THE TABLE BRAKE, BUT NO MALFUNCTION OF THE GEOMETRY WAS IDENTIFIED. THE LOG FILE SHOWED THAT AFTER A SYSTEM RESTART, THE IMAGE PROCESSING PC (IPPC) FAILED WHICH RESULTED IN THE SYSTEM NOT BEING OPERATIONAL. A PHILIPS SERVICE ENGINEER REPLACED THE IPPC AFTER WHICH THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER.

    Additional Manufacturer Narrative · 0

    THIS FINAL REPORT HAS BEEN CORRECTED AS PHILIPS WAS INFORMED THAT THE EVENT DATE WAS NOT ON (B)(6) 2021 TO BUT ON (B)(6) 2021. PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE INFORMATION COLLECTED, THE CUSTOMER INDICATED THAT IT WAS NOT POSSIBLE TO DO FLUOROSCOPY, EXPOSURE AND MOVE THE TABLE. THE SYSTEM WAS RESTARTED SEVERAL TIMES, BUT RESTARTS WERE UNSUCCESSFUL. PHILIPS HAS ANALYZED THE LOG FILE AND NO PROBLEM HAS BEEN IDENTIFIED WITH THE AVAILABILITY OF FLUOROSCOPY AND EXPOSURE. THE LOG FILE SHOWED AN UNUSUAL PATTERN WITH ENABLING AND DISABLING OF THE TABLE BRAKE, BUT NO MALFUNCTION OF THE GEOMETRY WAS IDENTIFIED. THE LOG FILE SHOWED THAT AFTER A SYSTEM RESTART, THE IMAGE PROCESSING PC (IPPC) FAILED WHICH RESULTED IN THE SYSTEM NOT BEING OPERATIONAL. A PHILIPS SERVICE ENGINEER REPLACED THE IPPC AFTER WHICH THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO PHILIPS THAT DURING AN EMERGENCY CORONARY PROCEDURE THE SYSTEM STOPPED WORKING. THE PATIENT WAS TRANSFERRED TO ANOTHER ROOM WHERE THE PROCEDURE WAS COMPLETED. NO HARM HAS BEEN REPORTED TO PHILIPS. PHILIPS HAS STARTED THE INVESTIGATION OF THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537023 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 00884838059054

    Patients

    Seq Age Sex Outcome Treatment
    1