BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLEASESIRIUS ANAESTHESIA SYSTEM

    MDR report key: 5088860 · Received September 18, 2015

    Report

    Report Number
    9611295-2015-00010
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Date of Event
    March 13, 2015
    Report Date
    September 18, 2015
    Manufacturer
    SPACELABS HEALTHCARE LTD.
    Product Code
    CBK
    PMA / PMN Number
    K051629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SENT TO CORRECT THE MANUFACTURER INFORMATION. THE OLD REPORT NUMBER WAS 3010157426-2015-00042. ONSITE INVESTIGATION BY A SPACELABS FIELD SERVICE ENGINEER (FSE) CONFIRMED THE INVOLVED DEVICE PERFORMED TO SPECIFICATIONS. BASED ON INFORMATION OBTAINED FROM THE EQUIPMENT LOGS, THERE WAS AN ALARM TRIGGERED BY THE FRESH GAS SETTING AT TOO HIGH A RATE DURING THE PATIENT CASE REPORTED IN THIS EVENT. THIS IS A USER SELECTABLE SETTING. WHEN THE USER SELECTABLE FRESH GAS SETTING IS TOO HIGH, IT PREVENTS BELLOWS MOVEMENT AS DESCRIBED IN THE COMPLAINT AND AN ALARM IS TRIGGERED TO ALERT THE USER. NO OTHER ISSUES WERE FOUND BASED IN THE EQUIPMENT LOG. THE PRODUCT WORKED AS DESIGNED; THERE WAS NO MALFUNCTION. THIS REPORT IS CONSIDERED COMPLETE AND THE ISSUE CLOSED.

    Additional Manufacturer Narrative · 1

    ON SITE INVESTIGATION BY A SPACELABS FIELD SERVICE ENGINEER (FSE) CONFIRMED THE INVOLVED DEVICE PERFORMED TO SPECIFICATIONS. BASED ON INFORMATION OBTAINED FROM THE EQUIPMENT LOGS, THERE WAS AN ALARM TRIGGERED BY THE FRESH GAS SETTING AT TOO HIGH A RATE DURING THE PATIENT CASE REPORTED IN THIS EVENT. THIS IS A USER SELECTABLE SETTING. WHEN THE USER SELECTABLE FRESH GAS SETTING IS TOO HIGH, IT PREVENTS BELLOWS MOVEMENT AS DESCRIBED IN THE COMPLAINT AND AN ALARM IS TRIGGERED TO ALERT THE USER. NO OTHER ISSUES WERE FOUND BASED IN THE EQUIPMENT LOG. THE PRODUCT WORKED AS DESIGNED; THERE WAS NO MALFUNCTION. THIS REPORT IS CONSIDERED COMPLETE AND THE ISSUE CLOSED. THIS REPORT IS BEING GENERATED AT THE DIRECTION OF FDA BECAUSE OF SUPPLEMENTAL REPORTS RECEIVED, WITH THIS MANUFACTURER REPORT NUMBER, AND NO RECORD OF AN INITIAL REPORT. THIS MANUFACTURER REPORT IS SUBMITTED TO CORRECT A PREVIOUS REPORT, 3010157426-2014-00042.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A BLEASE SIRIUS ANESTHESIA MACHINE LOST ALL PRESSURE READINGS, BELLOWS MOVEMENT, AND TIDAL VOLUME ON (B)(6) 2015 WHILE IN PATIENT USE. NO ONE WAS INJURED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620668 BLEASESIRIUS ANAESTHESIA SYSTEM ANAESTHESIA GAS-MACHINE CBK SPACELABS HEALTHCARE LTD. 14200100

    Patients

    Seq Age Sex Outcome Treatment
    1