BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA CV20

    MDR report key: 16122521 · Received January 9, 2023

    Report

    Report Number
    3003768277-2023-00128
    Event Type
    Malfunction
    Date Received
    January 9, 2023
    Date of Event
    December 16, 2022
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    PMA / PMN Number
    K141797
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE SYSTEM WAS OUTSIDE OF CLINICAL USE WHEN THE ISSUE OCCURRED. A PHILIPS FIELD SERVICE ENGINEER (FSE) INSPECTED THE SYSTEM ONSITE AND CONFIRMED THAT THE SYSTEM WAS NOT BOOTING UP. TROUBLESHOOTING ACTIONS SHOWED A SINGLE BOARD COMPUTER WAS FAILING. THE FSE REPLACED SBC. AFTER REPLACEMENT OF SBC, THE SYSTEM WAS 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 WAS NOT BOOTING UP. NO HARM HAS BEEN REPORTED TO PHILIPS. A PHILIPS SERVICE ENGINEER INSPECTED THE SYSTEM ON SITE. IT WAS IDENTIFIED THAT SBC WAS FAILING. THE SBC HAS BEEN REPLACED THAT THE SYSTEM WAS RETURNED TO USE IN GOOD WORKING ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2300592 ALLURA CV20 INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA CV20

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown