BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINITY ACS WORKSTATION CC

    MDR report key: 6154138 · Received December 8, 2016

    Report

    Report Number
    9611500-2016-00370
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Report Date
    December 8, 2016
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    CBK
    PMA / PMN Number
    K093633
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THE INVESTIGATION THE LOGBOOK AND THE PCB M16.2 WERE ANALYZED. THE REPORTED REBOOT COULD BE CONFIRMED. ACCORDING TO THE LOG ENTRIES THE VENTILATION UNIT V500 PERFORMED ONE WARMSTART ON (B)(6) 2016 AND CONTINUED TO VENTILATE THE PATIENT WITH THE PREVIOUS SETTINGS AFTERWARDS. THE ANALYSIS OF THE PCB M16.2 SHOWED THAT IT REACTS SENSITIVE TO SHOCKS. THEREFORE THE REBOOT WAS LIKELY DUE TO A FAILURE OF THE PCB. THE COMMUNICATION BETWEEN THE COCKPIT AND VENTILATION UNIT WAS INTERRUPTED IN THE MEANTIME WHICH WAS ALARMED BY THE DEVICE ACCORDINGLY. IN THE EVENT OF A REBOOT THE VENTILATION STOPS FOR AT MAXIMUM 8 SECONDS AND THE SAFETY VALVE OPENS AGAINST AMBIENT TO ALLOW FOR SPONTANEOUS BREATHING. AFTER THE REBOOT THE THERAPY CONTINUOUS WITH THE SET PARAMETERS, THE DEVICE ALARMS ACCORDINGLY. THE DEVICE REACTED ACCORDING TO ITS SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REBOOTS DURING VENTILATION. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807169 INFINITY ACS WORKSTATION CC VENTILATORS, INTENSIVE CARE CBK DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1