BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIRAFFE OMNIBED

    MDR report key: 5566856 · Received April 11, 2016

    Report

    Report Number
    5566856
    Event Type
    Malfunction
    Date Received
    April 11, 2016
    Date of Event
    March 11, 2016
    Report Date
    April 5, 2016
    Manufacturer
    GE HEALTHCARE LLC
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE GIRAFFE LOOKED LIKE IT HAD CRUMBS DOWN IN THE MOULDING AND WE WERE SUSPICIOUS OF SOME BLACK "CRUMBS" THAT LOOKED LIKE THEY WERE IN A CLUMP. THE GIRAFFE WAS PULLED FROM SERVICE AND SENT TO BIOMED. WE NOTICED THE NEW GIRAFFES HAVE A NEW MOULDING ON THEIR CANOPY THAT WOULD NOT ALLOW THESE "CRUMBS" TO COLLECT. BIOMED OPENED THE GIRAFFE MOULDING AND CALLED INFECTION PREVENTION TO TAKE A LOOK. THERE WAS A DARK BROWN SLIME BETWEEN THE OUTSIDE MOULDING AND GLASS. WE HAD OUR MICROBIOLOGY DEPARTMENT CULTURE FOR MOLD AND BACTERIA AND NOTHING GREW. WE DOUBLE-CHECKED THE RECALL SYSTEM AND DIDN'T SEE ANYTHING REGARDING THIS STYLE OF CANOPY MOULDING, BUT STILL WONDERED WHY THERE WAS A DESIGN CHANGE. THERE WERE A TOTAL OF 6 GIRAFFES THAT WERE IN DANGER OF HAVING THIS SAME TYPE OF MOULDING, SO ALL UNITS WERE PULLED AND CHECKED BY BIOMED. OF THESE 6 GIRAFFES, 4 UNITS WERE SERVICED FOR THIS ISSUE.

    Description of Event or Problem · 1

    THE GIRAFFE LOOKED LIKE IT HAD CRUMBS DOWN IN THE MOULDING AND WE WERE SUSPICIOUS OF SOME BLACK "CRUMBS" THAT LOOKED LIKE THEY WERE IN A CLUMP. THE GIRAFFE WAS PULLED FROM SERVICE AND SENT TO BIOMED. WE NOTICED THE NEW GIRAFFES HAVE A NEW MOULDING ON THEIR CANOPY THAT WOULD NOT ALLOW THESE "CRUMBS" TO COLLECT. BIOMED OPENED THE GIRAFFE MOULDING AND CALLED INFECTION PREVENTION TO TAKE A LOOK. THERE WAS A DARK BROWN SLIME BETWEEN THE OUTSIDE MOULDING AND GLASS. WE HAD OUR MICROBIOLOGY DEPARTMENT CULTURE FOR MOLD AND BACTERIA AND NOTHING GREW. WE DOUBLE-CHECKED THE RECALL SYSTEM AND DIDN'T SEE ANYTHING REGARDING THIS STYLE OF CANOPY MOULDING, BUT STILL WONDERED WHY THERE WAS A DESIGN CHANGE. THERE WERE A TOTAL OF 6 GIRAFFES THAT WERE IN DANGER OF HAVING THIS SAME TYPE OF MOULDING, SO ALL UNITS WERE PULLED AND CHECKED BY BIOMED. OF THESE 6 GIRAFFES, 4 UNITS WERE SERVICED FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223569 GIRAFFE OMNIBED INCUBATOR FMZ GE HEALTHCARE LLC OMNIBED

    Patients

    Seq Age Sex Outcome Treatment
    1