BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UVSL COMMAND MODULE

    MDR report key: 1060875 · Received June 13, 2008

    Report

    Report Number
    3023361-2008-00012
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    August 25, 2006
    Report Date
    June 13, 2008
    Manufacturer
    SPACELABS MEDICAL INC.
    Product Code
    DSI
    PMA / PMN Number
    K972502
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SPACELABS WAS NO INFORMED OF THE INCIDENT UNTIL APPROX. THREE WEEKS AFTER IT HAD OCCURRED. OUR INVESTIGATION DETERMINED THAT THE HOSPITAL STAFF COULD NOT IDENTIFY WHICH EQUIPMENT WAS IN USE AT THAT TIME, DID NOT PLACE CONTROLS ON THE EQUIPMENT AFTER THE INCIDENT, AND THEN CONTINUED TO USE THE EQUIPMENT IN QUESTION. THERE IS NO INFO AVAILABLE AS TO THE MONITOR/ MODULE SETTINGS OR WAVEFORMS FROM THE EVENT. COMMENTS FROM THE STAFF MADE DURING THE MEETING SUGGESTED THAT SPACELABS EQUIPMENT WAS NOT A CAUSAL FACTOR IN THIS INCIDENT. THE SPACELABS ATTENDEE AT THE MEETING REPORTED THAT THE ANESTHETIST INVOLVED STATED THAT THE ALARM VOLUMES WERE ADEQUATE, AS HE HAD HEARD THEM IN THE TWO PREVIOUS CASES WITHIN THE OR. FOLLOWING NOTIFICATION OF THIS INCIDENT, WE REMINDED THE HOSPITAL STAFF OF THEIR ABILITY TO SET A MINIMUM VOLUME LEVEL WITHIN THE (PASSWORD PROTECTED) MEMORY OF THE MONITORS. SUCH SETTINGS PREVENT THE ALARM VOLUME FROM BEING INADVERTENTLY SET BELOW A CERTAIN LEVEL. REVIEW OF OUR POST MARKET SURVEILLANCE HAS REVEALED THAT SPACELABS HAD NOT PREVIOUSLY SUBMITTED A REPORT OF THIS INCIDENT TO THE FDA.

    Description of Event or Problem · 1

    SPACELABS PRESENCE WAS REQUESTED BY THE COMPANY TO ANSWER ANY MONITOR RELATED QUESTIONS THAT MIGHT ARISE DURING A MEETING BETWEEN HOSPITAL AND THE COMPANY. THE MEETING WAS IN CONNECTION WITH AN INCIDENT THAT HAD OCCURRED APPROX. THREE WEEKS EARLIER. IT WAS ALLEGED THAT A PT HAD SUFFERED HYPOXIC BRAIN DAMAGE DURING AN OR PROCEDURE AND NO AUDIBLE SPO2 ALARM WAS HEARD BY THE OR STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UVSL COMMAND MODULE NONE DSI SPACELABS MEDICAL INC. 91496

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening