BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GIRAFFE OMNIBED

    MDR report key: 4173281 · Received September 29, 2014

    Report

    Report Number
    4173281
    Event Type
    Malfunction
    Date Received
    September 29, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 29, 2014
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    FMZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US

    Narratives

    Description of Event or Problem · 1

    EIGHT OF THE 21 GIRAFFE OMNIBED UNITS HAVE HAD TO HAVE THE COVER LIFT RAIL REPLACED (38%). ALL BUT ONE OF THESE UNITS WAS PURCHASED IN 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605260 GIRAFFE OMNIBED INCUBATOR, NEONATAL FMZ OHMEDA MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *