BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA

    MDR report key: 5046170 · Received September 1, 2015

    Report

    Report Number
    1220063-2015-00025
    Event Type
    Injury
    Date Received
    September 1, 2015
    Date of Event
    August 27, 2015
    Report Date
    October 27, 2015
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC
    Product Code
    CBK
    PMA / PMN Number
    K070566
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS STARTED BUT HAS NOT YET BEEN CONCLUDED. THE INVESTIGATION RESULT WILL BE REPORTED IN THE FOLLOW UP-REPORT.

    Additional Manufacturer Narrative · 1

    THE AFFECTED DELTA MONITOR, SPO2 PROBE AND THE LOG FILES OF THE DELTA AND THE INFINITY CENTRAL STATION WERE PROVIDED FOR THE INVESTIGATION. TESTING OF THE SPO2 PROBE AND THE DELTA DID NOT REVEAL ANY DEVIATION AND BOTH PASSED THE FUNCTIONAL SYSTEM TEST. THE LOG FILES OF THE DELTA SHOWED THAT THE LOWER ALARM LIMIT FOR SPO2 WAS SET TO 95. LOG ENTRIES SHOW THAT THE LOWER LIMIT WAS VIOLATED AT 13:44:15 ON (B)(6) WITH A SPO2 PARAMETER VALUE OF 55 AND AN ALARM FOR "LOW OXYGEN SATURATION" WAS POSTED ACCORDINGLY TO ALERT THE USER. THE REPORTED OXYGEN SATURATION OF 7 COULD NOT BE CONFIRMED. THERE IS NO INDICATION IN THE LOGS THAT THE BED WAS SILENCED OR PAUSED DURING THE LOW SATURATION READING AND THERE WAS NO INDICATION OF LOST ALARM MESSAGES DURING THIS TIME AS WELL. THE LOGS DO NOT RECORD THE ALARM TONE VOLUME SETTING AT THE BEDSIDE MONITOR AND THEREFORE IT CANNOT BE DETERMINED WHAT THE ALARM VOLUME WAS SET TO. THE LOG FILES SHOW THAT AN ALARM WAS POSTED FOR LOW OXYGEN SATURATION. TESTING OF THE DEVICE AFTER THE EVENT SHOWED THAT THE ALARM SYSTEM OF THE DELTA IS OPERATING AS INTENDED. CONSEQUENTLY, THE REPORTED MALFUNCTION OF THE DELTA MONITOR COULD NOT BE CONFIRMED AFTER THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT CAME FROM THE OPERATION ROOM AND WAS EXTUBATED ON THE INTENSIVE WARD. A SHORT TIME LATER A NURSE, WHICH PASSED THE ROOM, NOTICED THAT THE C700 AND THE DELTA MONITOR DISPLAYED A OXYGEN SATURATION OF "7". THE DELTA MONITOR REPORTEDLY HAS GIVEN NEITHER AN OPTICAL NOR A ACOUSTICAL ALARM. PATIENT SHOWED NO LONGER A BREATHING AND HAD TO BE RESUSCITATED. SKIN AND PUPILS OF THE PATIENT WERE WHITE. TODAY THE PATIENT IS IN AN STABLE CONDITION AND RESPONSIVE. THE MONITORS WERE NOT CONNECTED TO THE CENTRAL. COMPLAINT REFERENCE (B)(4).

    Description of Event or Problem · 1

    PLEASE SEE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577791 DELTA PHYSIOLOGICAL MONITORING SYSTEMS CBK DRAEGER MEDICAL SYSTEMS, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening