BEUDAMED
    FDA Adverse Event Death Summary report: N

    GIRAFFE OMNIBED

    MDR report key: 2312331 · Received October 21, 2011

    Report

    Report Number
    1121732-2011-00003
    Event Type
    Death
    Date Received
    October 21, 2011
    Date of Event
    May 8, 2011
    Report Date
    October 21, 2011
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMZ
    PMA / PMN Number
    K101788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL IS CURRENTLY CHANGING THEIR CLEANING POLICIES AND IMPLEMENTING CHANGES OF BOTH HOW AND WHEN TO CLEAN THE MICROENVIRONMENTS. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. THE HOSPITAL INITIALLY CONTACTED GE HEALTHCARE TO INQUIRE ABOUT THE CLEANING PROCEDURES FOR THE GIRAFFE OMNIBED. BASED ON THE INFO AVAILABLE AT THIS TIME, IT IS UNK WHETHER THE EVENT IS ATTRIBUTABLE TO THE DEVICE. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. (B)(6). THE SERIAL NUMBER OF THE DEVICE INVOLVED IN THIS CASE COULD NOT BE OBTAINED FROM THE FACILITY; CONSEQUENTLY, NEITHER THE SERIAL NUMBER, NOR THE DEVICE MANUFACTURE DATE CAN BE DETERMINED. THE 510(K) NUMBER PROVIDED IS THE MOST CURRENT CLEARED PREMARKET NOTIFICATION FOR THE GIRAFFE OMNIBED.

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT AN INFANT BEING TREATED IN A GIRAFFE OMNIBED HAD DIED WITH A POSITIVE CULTURE FOR (B)(6) INFECTION. THE INFANT WAS REPORTEDLY BEING TREATED WITH GREATER THAN 80% HUMIDITY IN THE MICROENVIRONMENT AND BED TEMPERATURES BETWEEN 37 AND 38 DEGREES CELSIUS. THE HOSPITAL PERFORMED RANDOM CULTURES ON A GIRAFFE OMNIBED AND AN OSCILLATOR WITH NEGATIVE RESULTS. THE HOSPITAL IS REPORTEDLY UNDERGOING EXTENSIVE RENOVATION, INCLUDING THE NICU (NEONATAL INTENSIVE CARE UNIT), AND A COMMENT WAS MADE AS TO WHETHER THE CONSTRUCTION PROJECT MAY HAVE AFFECTED THE WATER. THE TWO INFANTS WERE REPORTEDLY LOCATED IN AREAS OF THE NICU THAT SHARED A COMMON SINK. THE HOSPITAL STAFF IS BEING RE-EDUCATED IN AND WASHING PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIRAFFE OMNIBED NEONATAL INCUBATOR FMZ OHMEDA MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Death