BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXAM LIGHT AFIXED TO INCUBATOR

    MDR report key: 2113406 · Received May 29, 2011

    Report

    Report Number
    MW5020836
    Event Type
    Injury
    Date Received
    May 29, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 29, 2011
    Manufacturer
    GE HEALTH SYSTEMS/OHMEDA
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN (B)(6) 2008 WE PURCHASED GIRAFFE INCUBATORS MADE BY GE HEALTH SYSTEMS WHICH HAVE AS PART OF THE OVERALL ENSEMBLE AN ATTACHED EXAM LIGHT FROM OHMEDA. WE NOTED 2 ISSUES WITH THE ATTACHED LIGHT: THE PLASTIC CASING AROUND THE LIGHT IS MELTING OVER TIME AND IS NOW MISSHAPEN AND CAN EASILY BREAK OFF; THE PLASTIC COVERING OF THE GOOSENECK HAS TORN AND IS DISINTEGRATING MAKING IT IMPOSSIBLE TO CLEAN. DATES OF USE: FROM (B)(6) 2008 TO (B)(6) 2011. DIAGNOSIS OR REASON FOR USE: PREMATURE INFANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXAM LIGHT AFIXED TO INCUBATOR EXAM LIGHT FMZ GE HEALTH SYSTEMS/OHMEDA GIRAFFE OMNIBED
    2 EXAM LIGHT AFIXED TO INCUBATOR EXAM LIGHT FMZ GE HEALTH SYSTEMS/OHMEDA GIRAFFE OMNIBED
    3 EXAM LIGHT AFIXED TO INCUBATOR EXAM LIGHT FMZ GE HEALTH SYSTEMS/OHMEDA GIRAFFE OMNIBED

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention