BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLEASESIRIUS ANAESTHESIA SYSTEM

    MDR report key: 5089077 · Received September 18, 2015

    Report

    Report Number
    9611295-2015-00013
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Date of Event
    April 20, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SENT TO CORRECT THE MANUFACTURER INFORMATION. THE OLD REPORT NUMBER WAS 3010157426-2015-00106. A SPACELABS FIELD SERVICE ENGINEER WAS DISPATCHED TO THE SITE TO MAKE REPAIRS. THE BELLOWS ASSEMBLY WAS DETERMINED TO BE THE SOURCE OF A LEAK AND WAS THEREFORE REPLACED. THE ANESTHESIA DEVICE PASSES ALL PERFORMANCE TESTS AND WAS RETURNED TO SERVICE. THE FAULTY BELLOWS ASSEMBLY WAS SENT TO SPACELABS FOR FURTHER TESTING. A SPACELABS PRODUCT SUPPORT SPECIALIST CONFIRMED THE POP OFF VALVE COMPONENT OF THE BELLOWS ASSEMBLY WAS THE ROOT CAUSE OF THE LEAK. THIS SUPPLEMENTAL REPORT IS CONSIDERED FINAL AND THE ISSUE CLOSED.

    Additional Manufacturer Narrative · 1

    A SPACELABS FIELD SERVICE ENGINEER WAS DISPATCHED TO THE SITE TO MAKE REPAIRS. THE BELLOWS ASSEMBLY WAS DETERMINED TO BE THE SOURCE OF A LEAK AND WAS THEREFORE REPLACED. THE ANESTHESIA DEVICE PASSES ALL PERFORMANCE TESTS AND WAS RETURNED TO SERVICE. THE FAULTY BELLOWS ASSEMBLY WAS SENT TO SPACELABS FOR FURTHER TESTING. A SPACELABS PRODUCT SUPPORT SPECIALIST CONFIRMED THE POP OFF VALVE COMPONENT OF THE BELLOWS ASSEMBLY WAS THE ROOT CAUSE OF THE LEAK. THIS SUPPLEMENTAL REPORT IS CONSIDERED FINAL 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, 3010157426-2014-00106, THAT MISTAKENLY IDENTIFIED THE MANUFACTURER REPORT NUMBER; AT FDA FORM 3500A TOP OF PAGE 1 AND SECTION G(9) AND MISTAKENLY IDENTIFIED THE MANUFACTURER IN SECTION D(3) BY LISTING THE MANUFACTURE¿S AFFILIATE ENTITY.

    Description of Event or Problem · 1

    SPACELABS RECEIVED A REPORT THAT A BLEASE SIRIUS ANESTHESIA SYSTEM MODEL 14200100 HAD BELLOWS FAILURE DURING PATIENT USE ON (B)(6) 2015. NO ONE WAS INJURED AS THE RESULT OF THIS EVENT. THE CLINICIAN USED THE BAG MODE TO COMPLETE THE PROCEDURE WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620661 BLEASESIRIUS ANAESTHESIA SYSTEM ANAESTHESIA GAS-MACHINE CBK SPACELABS HEALTHCARE LTD. 14200100 07-NOV-2012

    Patients

    Seq Age Sex Outcome Treatment
    1