BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AISYS CS2

    MDR report key: 5470355 · Received March 1, 2016

    Report

    Report Number
    2112667-2016-00398
    Event Type
    Malfunction
    Date Received
    March 1, 2016
    Date of Event
    February 9, 2016
    Report Date
    March 1, 2016
    Manufacturer
    DATEX-OHMEDA, INC.
    Product Code
    BSZ
    PMA / PMN Number
    K132530
    Removal / Correction Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DRIVE GAS CHECK VALVE COULD BECOME STUCK IN A FIXED OPEN POSITION WHICH COULD CAUSE PRESSURE TO BUILD IN THE MECHANICAL VENTILATION CYCLE. IF THIS ISSUE IS LEFT UNRESOLVED, IT COULD RESULT IN EXCESSIVE OR PROLONGED PRESSURE IN THE PATIENT BREATHING CIRCUIT DURING VENTILATION POTENTIALLY RESULTING IN BAROTRAUMA. GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR THIS ISSUE PER 21 CFR 806 ON (B)(6) 2015. THE RECALL CLASSIFICATION NUMBER IS Z-0677-2016 THROUGH Z-0682-2016. NO REPORT OF PATIENT INVOLVEMENT. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. THE DRIVE GAS CHECK VALVE COULD BECOME STUCK IN A FIXED OPEN POSITION WHICH COULD CAUSE PRESSURE TO BUILD IN THE MECHANICAL VENTILATION CYCLE. IF THIS ISSUE IS LEFT UNRESOLVED, IT COULD RESULT IN EXCESSIVE OR PROLONGED PRESSURE IN THE PATIENT BREATHING CIRCUIT DURING VENTILATION POTENTIALLY RESULTING IN BAROTRAUMA. GE HEALTHCARE (GEHC) REPORTED A FIELD MODIFICATION FOR THIS ISSUE PER 21 CFR 806 ON (B)(6) 2015. THE RECALL CLASSIFICATION NUMBER IS Z-0677-2016 THROUGH Z-0682-2016. NO REPORT OF PATIENT INVOLVEMENT. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT, DURING A PREOPERATIVE CHECKOUT, POSITIVE END EXPIRATORY PRESSURE WAS HIGHER THAN EXPECTED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128644 AISYS CS2 ANESTHESIA GAS MACHINE BSZ DATEX-OHMEDA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1