BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACELABS MULTIGAS ANALYZER MODULE

    MDR report key: 2564426 · Received May 8, 2012

    Report

    Report Number
    3023361-2012-00019
    Event Type
    Malfunction
    Date Received
    May 8, 2012
    Date of Event
    April 15, 2012
    Report Date
    September 6, 2012
    Manufacturer
    SPACELABS MEDICAL INC.
    Product Code
    CBR
    PMA / PMN Number
    K053599
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THREE DEVICE FAILURES AND STATED THAT THEY WERE SAFETY ISSUES. WE FILED AN MDR BECAUSE OF THE CUSTOMER'S CONCERN. WE DOCUMENTED THE OTHER TWO IN MDRS 3023361-2012-00020 AND 3023361-2012-00021. THE SUBJECT DEVICE WAS FIRST SENT BY THE CUSTOMER TO THEIR SERVICE PROVIDER WHO WAS UNABLE TO FIX THE ISSUE. THE DEVICE WAS THEN RETURNED TO SPACELABS FOR REPAIR. SPACELABS REPLACED THE GAS BENCH AND SOLVED THE ISSUE. THE DEVICE WAS RETURNED TO THE HOSPITAL AND PUT BACK INTO SERVICE. THERE HAS BEEN NO FURTHER REPORT ON THIS ISSUE. THE GAS BENCH IS AN OEM PRODUCT. SPACELABS REPLACED THE GAS BENCH IN QUESTION AND RETURNED IT TO THE MANUFACTURER FOR INVESTIGATION AND TRENDING. GE HAS NOT INDICATED THERE IS A SIGNIFICANT TREND OF THIS FAILURE. NO ONE HAS BEEN INJURED AS A RESULT OF THIS FAILURE. WE HAVE CONCLUDED THAT THIS REPORT IS FINAL AND CONSIDER THIS ISSUE CLOSED.

    Additional Manufacturer Narrative · 1

    SPACELABS IS WORKING TO CONTACT THE HOSPITAL TO OBTAIN DETAILS OF THE REPORTED EQUIPMENT MALFUNCTION. NO ONE HAS BEEN INJURED AS A RESULT OF THIS ALLEGED MALFUNCTION. WE WILL PROVIDE A SUPPLEMENTAL REPORT ONCE OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SPACELABS RECEIVED INFORMATION THAT ALLEGES THAT A MULTIGAS ANALYZER MODULE FAILED.

    Description of Event or Problem · 1

    SPACELABS RECEIVED INFORMATION THAT ALLEGES THAT A MULTIGAS ANALYZER MODULE FAILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACELABS MULTIGAS ANALYZER MODULE ANESTHESIA GAS ANALYZER MODULE CBR SPACELABS MEDICAL INC. 91518

    Patients

    Seq Age Sex Outcome Treatment
    1