BEUDAMED
    FDA Adverse Event Death Summary report: N

    GIRAFFE OMNIBED

    MDR report key: 2102302 · Received May 17, 2011

    Report

    Report Number
    1121732-2011-00001
    Event Type
    Death
    Date Received
    May 17, 2011
    Date of Event
    April 9, 2011
    Report Date
    May 17, 2011
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMZ
    PMA / PMN Number
    K101788
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. THE INFANT AGE WAS (B)(6) GESTATION. THE HOSPITAL WAS CONTACTED MULTIPLE TIMES TO OBTAIN DEVICE SPECIFIC INFO. THE HOSPITAL HAS BEEN SOLD FIVE (5) GIRAFFE OMNIBEDS WITH MANUFACTURE DATES RANGING FROM 2003 TO 2010. 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. THERE WAS NO ALLEGATION OF A DEVICE MALFUNCTION. INVESTIGATION INTO WHETHER IMPROPER CLEANING OF THE GIRAFFE OMNIBED MAY HAVE CONTRIBUTED TO THE DEATH IS CURRENTLY UNDER WAY. BASED ON THE INFO AVAILABLE AT THIS TIME, THIS EVENT IS REPORTABLE AS A USER ERROR.

    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 3 DA Death