BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIRAFFE OMNIBED

    MDR report key: 7705876 · Received July 20, 2018

    Report

    Report Number
    1121732-2018-00007
    Event Type
    Injury
    Date Received
    July 20, 2018
    Date of Event
    May 25, 2018
    Report Date
    September 28, 2018
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMZ
    PMA / PMN Number
    K101788
    Removal / Correction Number
    GEHC FMI 32063
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    GE HEALTHCARE HAS BECOME AWARE OF A POTENTIAL SAFETY ISSUE THAT CAN OCCUR IF THE CANOPY SEALS ARE NOT CLEANED APPROPRIATELY PER GIRAFFE OMNIBED CLEANING AND CARE GUIDELINES ON SYSTEMS WITH ORIGINAL SEAL DESIGN. REPORTED BUILDUP OF DEBRIS AROUND THE EDGE OF THE CANOPY SEAL CAN LEAD TO A SOURCE OF INFECTION. GE HEALTHCARE (GEHC) IS INITIATING AND WILL BE REPORTING A FIELD MODIFICATION FOR THIS ISSUE PER 21 CFR 806. THE GEHC INTERNAL FIELD MODIFICATION NUMBER IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE PREMATURE INFANT WITH THE POSITIVE BLOODSTREAM INFECTION WAS (B)(6) AT TIME OF INCIDENT OF FINDING THE REPORTED BLACK STICKY SUBSTANCE, WEIGHED (B)(6) AT BIRTH AND (B)(6) AT TIME OF THE INCIDENT AND IS MALE. THE RANGE OF GESTATIONAL AGES AT BIRTH OF THE BABIES WHO WERE COLONIZED WAS (B)(6), THEIR WEIGHT RANGE WAS 590-800GMS. REPORT SOURCE: USER REPORT MW5077713. DEVICE IDENTIFICATION NUMBER AND DATE OF DEVICE MANUFACTURE: THE REPORTED SERIAL NUMBERS AND RESPECTIVE DATES OF MANUFACTURES ARE AS FOLLOWS: (B)(4): DECEMBER 2002, (B)(4): JUNE 2007, (B)(4): JULY 2007, (B)(4): APRIL 2008, (B)(4): NOV 2010, (B)(4): SEPT 2012. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    SIX OMNIBEDS IN USE FOR PREMATURE INFANTS FROM ONE SITE WERE FOUND TO HAVE A BLACK STICKY SUBSTANCE UNDER THE CANOPY SEAL. THE BLACK STICKY SUBSTANCE WAS CULTURED AND GREW SERRATIA MARCESCENS. THE 6 PREMATURE INFANTS CURRENTLY USING THE OMNIBEDS WERE CULTURED WITH SURFACE SWABS (RECTAL) AND BLOOD CULTURES. TWO INFANTS WERE NEGATIVE FOR ALL CULTURES; THREE INFANTS WERE FOUND TO BE COLONIZED AND HAD POSITIVE SURFACE SWABS; AND ONE INFANT HAD A POSITIVE BLOOD CULTURE INDICATING BLOODSTREAM INFECTION. THE 3 COLONIZED INFANTS AND THE INFANT WITH THE POSITIVE BLOOD CULTURE WERE TREATED WITH A COURSE OF ANTIBIOTICS. ONE OF THE COLONIZED INFANTS DIED AS A RESULT OF COMORBIDITIES AND WAS NOT RELATED TO SERRATIA MARCESCENS ACCORDING TO THE CUSTOMER MEDICAL STAFF. IT COULD NOT BE DETERMINED WHICH INFANT WAS IN EACH AFFECTED OMNIBED AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547399 GIRAFFE OMNIBED NEONATAL INCUBATOR FMZ OHMEDA MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Other