BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRAEGER ISOLETTE INCUBATOR

    MDR report key: 2447890 · Received February 3, 2012

    Report

    Report Number
    2510954-2012-00001
    Event Type
    Other
    Date Received
    February 3, 2012
    Date of Event
    October 31, 2011
    Report Date
    January 3, 2012
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC.
    Product Code
    FMZ
    PMA / PMN Number
    K960980
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DRAEGER COMPLETED THE INVESTIGATION FOR THIS REPORT. ON (B)(4) 2012, A USER REPORT WAS RECEIVED FROM THE FACILITY DESCRIBING THE INCIDENT. WHILE IN THE TWIN ADMIT ROOM THE AIR TEMPERATURE SET POINT WAS REDUCED TO 31 DEG C AS THE PT'S TEMPERATURE RANGED FROM 98.0 TO 99.1 DEG F. THE SEQUENCE OF EVENT LEADING UP TO THE INCIDENT INDICATES THE USER UNPLUGGED THE DEVICE TO MOVE IT TO A SINGLE PT ROOM, THEN PLUGGED IT BACK IN AFTER THIS RELOCATION. THERE IS NO INDICATION THAT THE USER VERIFIED THE PREVIOUS TEMPERATURE SETTING AFTER RE-ENERGIZING THE DEVICE BEFORE EXITING THE AREA. THE AMOUNT OF TIME THAT TRANSPIRED BETWEEN THE MOVE FROM ONE ROOM TO THE OTHER EXCEEDED THE 10 MINUTES WINDOW ALLOWANCE BEFORE THE DEVICE REVERTS BACK TO THE FACTORY DEFAULT AIR SET TEMPERATURE OF 35.0 DEG C. THE PT'S TEMPERATURE WAS ALLEGED TO HAVE ELEVATED TO 104.2 DEG F AS A RESULT OF THE AIR SET POINT CHANGE; HOWEVER, THERE WAS NO INDICATION THAT ANY PT INJURY HAD OCCURRED AS A RESULT OF THIS REPORT. IT WAS ALSO ALLEGED THAT THIS SCENARIO HAS OCCURRED ON MANY DIFFERENT OCCASIONS; HOWEVER, THERE WERE NO OTHER REPORTED COMPLAINTS FILED. THE INSTRUCTIONS FOR USE SECTION "SYSTEM CONFIGURATION MENU" NOTES UNDER "DEFAULT SETTINGS", IN THE EVENT OF A POWER FAILURE LASTING 10 MINUTES OR LESS, THE SET POINTS AND OPERATING MODE ARE RETAINED. WITH POWER FAILURES LASTING MORE THAN 10 MINUTES, THE SET POINTS AND OPERATING MODE REVERT TO FACTORY DEFAULTS SETTINGS OR TO THE SETTINGS SELECTED IN THE CONFIGURATION MENU." IN THIS CASE THE FACTORY DEFAULT SETTING FOR AIR SET TEMPERATURE IS 35.0 DEG C. THE SYSTEM CONFIGURATION MENU ENABLES THE USER TO VIEW AND CHANGE CONFIGURABLE SYSTEM PARAMETER. THE FACTORY DEFAULT SETTINGS CAN BE CONFIGURED BY THE USER BASED ON THE TABLE IN THIS SECTION UNDER "SETTING OPTIONS" IF ALTERNATE SETTINGS ARE DESIRED OTHER THAN THE FACTORY DEFAULT SETTINGS. BASED ON THE REVIEW OF THE SEQUENCE OF EVENTS LEADING UP TO THE INCIDENT; THERE IS NO INDICATION THAT THE DEVICE DID NOT FUNCTION AS INTENDED, ACCORDING TO MFR SPECIFICATIONS. IT APPEARS THAT THE USER DID NOT VERIFY THE TEMPERATURE SETTING AFTER RE-ENERGIZING THE DEVICE AND EXITING THE AREA. THE INSTRUCTIONS FOR USE CLEARLY INSTRUCT THE USER ON POWER FAIL SCENARIOS IN REGARD TO TIME LIMITS AND THE EXPECTED RESULTS AND ALSO THE USER'S ABILITY TO CHANGE THE FACTORY DEFAULT SETTINGS AS CALLED OUT IN THE TABLE IN THE SYSTEM CONFIGURATION MENU.

    Description of Event or Problem · 1

    TWIN INFANTS WERE MOVED FROM A TWIN ADMIT ROOM TO A SINGLE PT ROOM. THEIR UNITS WERE UNPLUGGED AND PLUGGED BACK IN, IN THE NEXT ROOM. THE NURSE WAS AWARE THAT ONCE UNPLUGGED THE TEMPERATURE AIR CONTROL DEFAULTS BACK TO 35 DEG C. THE PTS HAS BEEN IN A 31.6 - 32.5 DEG C BED FOR THE PREVIOUS 24 HOURS. THE PTS WERE MOVED TO THE ROOM AT 1700 AT WHICH TIME THE TEMPERATURE WAS RANGING FROM 98.0 - 99.1 DEG F WAS THE TEMP AT 1700 SO THE UNIT TEMPERATURE WAS DECREASED TO 31 DEG C. THE NEXT TEMPERATURE WAS TAKEN AT 2050 AND REVEALED AN AXILLARY TEMPERATURE FOR THE PT OF 104.2 DEG F (THIS ALSO OCCURRED TO THE TWIN BROTHER, BUT HIS TEMPERATURE REACHED ONLY 100 DEG F). THE PHYSICIAN WAS NOTIFIED AND A CBC WAS OBTAINED. BECAUSE THE UNIT DEFAULTS BACK TO THE TEMPERATURE OF 35 DEG C, IT HAS THE POTENTIAL FOR ERROR AND RISK TO THE PT. IN SPEAKING TO THE STAFF, THIS HAS OCCURRED ON MANY DIFFERENT OCCASIONS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAEGER ISOLETTE INCUBATOR INFANT INCUBATOR FMZ DRAEGER MEDICAL SYSTEMS, INC. I 8000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA