BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIRAFFE OMNIBED INFANT WARMER/INCUBATOR

    MDR report key: 9769786 · Received February 27, 2020

    Report

    Report Number
    MW5093363
    Event Type
    Malfunction
    Date Received
    February 27, 2020
    Report Date
    January 30, 2020
    Manufacturer
    OHMEDA MEDICAL/GE HEALTHCARE LLC
    Product Code
    FMT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RECALL OF OHMEDA GIRAFFE OMNIBED INFANT WARMER/INCUBATOR. THE ABOVE GE GIRAFFE OMNIBED INFANT INCUBATOR/WARMER WAS PURCHASED REFURBISHED FROM (B)(6) WITH DELIVERY ON (B)(6) 2019. WE RECEIVED FROM THEM A RECALL NOTICE AS FOLLOWS: QUALITY ASSURANCE ADVISORY, (QAA): NO. 2019-12-19-010 REFERENCING GE HEALTHCARE: CLASS I RECALL-DUE TO POTENTIAL FOR INFANTS TO FALL. INFORMATION STATES THAT THERE IS NOT MUCH DIFFERENCE IN APPEARANCE OF SIDE RAIL BEING LATCHED OR UNLATCHED, WHICH COULD RESULT IN AN INFANT FALL. WE ARE A SCHOOL OF NURSING. OUR BED IS USED FOR A NEWBORN MANIKIN ONLY, NOT REAL INFANTS. THEREFORE IT IS CATEGORIZED ON THE QAA AS NON-SERIOUS TYPE II FOR OUR FACILITY. PLEASE ADVISE OF FURTHER THINGS WE NEED TO DO TO GET THE LATCHES FIXED OR LABELLED IN ORDER TO COMPLETELY REMEDY THIS RECALL. THANK YOU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229481 GIRAFFE OMNIBED INFANT WARMER/INCUBATOR WARMER, INFANT, RADIANT FMT OHMEDA MEDICAL/GE HEALTHCARE LLC OMNIBED ENG EBASE S

    Patients

    Seq Age Sex Outcome Treatment
    1 N/A