BEUDAMED
    FDA Adverse Event Other Summary report: N

    GIRAFFE OMNIBED

    MDR report key: 1033283 · Received March 17, 2008

    Report

    Report Number
    1121732-2008-00003
    Event Type
    Other
    Date Received
    March 17, 2008
    Date of Event
    November 29, 2007
    Report Date
    March 12, 2008
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMT
    PMA / PMN Number
    K020543
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: STANDARD CLINICAL PRACTICE, ENVIRONMENTAL INFECTION CONTROL PRACTICES AND EQUIPMENT PREVENTIVE MAINTENANCE IN THE NEONATAL INTENSIVE CARE UNIT INCLUDE BUT ARE NOT LIMITED TO THE FOLLOWING: CLINICAL MONITORING BY HCP OF INFANT STATUS AND HIGH LEVEL OF SUSPICION FOR INFECTION. THE KNOWN IMMUNOCOMPROMISED STATE AND FREQUENT SKIN INSULTS LEAD TO PORTAL OF ENTRIES FOR PATHOGENS OF NEONATE. ADHERENCE TO INFECTION CONTROL STANDARDS IN CONJUNCTION WITH HAND WASHING AMONG HCPS IS PRIMARY METHOD TO DECREASE NOSOCOMIAL TRANSMISSION OF PATHOGENS TO NEONATE. REMOVING CONTAMINATED DEVICE FROM PT CARE AND STRICT ADHERENCE TO CLEANING OF MEDICAL DEVICES. OPERATOR MANUAL RECOMMENDATIONS FOR CLEANING, USE OF HUMIDIFICATION SYSTEMS, AND FILTER CHANGES. PREVENTING ACCUMULATION OF DUST AND MOISTURE FROM ANY PT CARE SURFACE DECREASES ENVIRONMENT KNOWN MICROORGANISM GROWTH AND/OR TRANSMISSION. SURVEILLANCE AND MONITORING OF HOSPITAL SPECIFIC ORGANISMS BY INFECTION CONTROL. GE HEALTHCARE HAS UPDATED THE OMNIBED LABELING AND CLEANING INSTRUCTIONS TO MORE CLEARLY INDICATE CLEANING OF THE SEALS.

    Description of Event or Problem · 1

    CULTURE REPORT RECEIVED FROM HOSPITAL INDICATED THE PRESENCE OF PSEUDOMONAS ORYZIHABITANS. LOCATION FROM WHERE THE CULTURE WAS TAKEN IS NOT KNOWN. THERE WAS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GIRAFFE OMNIBED INFANT WARMER/INCUBATOR FMT OHMEDA MEDICAL 6600-0237-850

    Patients

    Seq Age Sex Outcome Treatment
    1