BEUDAMED
    FDA Adverse Event Injury Summary report: N

    700/900 SERIES VENTILATOR (FOR BLEASESIRIUS)

    MDR report key: 936441 · Received October 31, 2007

    Report

    Report Number
    9614357-2007-00001
    Event Type
    Injury
    Date Received
    October 31, 2007
    Date of Event
    October 15, 2007
    Report Date
    October 30, 2007
    Manufacturer
    SPACELABS HEALTHCARE LTD.
    Product Code
    BSZ
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE IS THE SUBJECT OF A FIELD CORRECTIVE ACTION THAT HAS BEEN REPORTED TO THE FDA CDRH OFFICE OF COMPLIANCE. THIS REPORT IS INTENDED TO SERVE AS BOTH THE INITIAL AND FINAL MEDICAL DEVICE REPORT ON THIS MATTER.

    Description of Event or Problem · 1

    IN PRESSURE CONTROL VENTILATION MODE, THE VENTILATOR CAN BE CAUSED TO OVER PRESSURE WHEN PLACED UNDER SINGLE FAULT CONDITION(S). IT WAS DETERMINED THROUGH IN-HOUSE VALIDATION WORK ON A NEW VERSION OF CONTROL SOFTWARE, THAT WHEN IN PCV MODE THE VENTILATOR WOULD OVER PRESSURE WHEN THE PATIENT SENSOR WAS NOT CONNECTED IN CIRCUIT OR (TO A LESSER DEGREE), WHEN THE PATIENT SENSOR TUBING WAS OCCLUDED (I.E. SINGLE FAULT CONDITION APPLIED). WHEN THE PATIENT SENSOR WAS NOT CONNECTED, DELIVERED PRESSURE ROSE OVER 2 TO 3 BREATHS TO THE INTERNALLY SET LIMIT OF 50 CM H2O AND WAS REPEATED FOR EACH SUBSEQUENT BREATH. THE FAULT CONDITION WAS WORST WITH THE PAEDIATRIC BELLOWS AND 15MM PATIENT BREATHING CIRCUIT SETUP (SMALLER VOLUME). NB: THIS MATTER HAS NOT BEEN RAISED AS THE RESULT OF ANY ADVERSE INCIDENT REPORT TO SPACELABS HEALTHCARE BUT WAS IDENTIFIED IN-HOUSE, UNDER TEST CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 700/900 SERIES VENTILATOR (FOR BLEASESIRIUS) ANESTHESIA VENTILATOR (SYSTEM) BSZ SPACELABS HEALTHCARE LTD. BLEASESIRIUS

    Patients

    Seq Age Sex Outcome Treatment
    1 YR