BEUDAMED
    FDA Adverse Event Summary report: N

    GIRAFFE T-PIECE

    MDR report key: 2982677 · Received February 21, 2013

    Report

    Report Number
    MW5029137
    Date Received
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    GE HEALTHCARE, LLC
    Product Code
    BTL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DATE OF REPLY: SOURCE (B)(6), GIRAFFE AND PANDA T-PIECE RESUSCITATION SYSTEMS AND MASK RESUSCITATION SYSTEMS: CLASS 1 RECALL - POTENTIAL REVERSAL OF OXYGEN/AIR: MEDICAL LOGISTICS CONDUCTED A SEARCH ON THE EQUIPMENT DATABASE. THIS PARTICULAR EQUIPMENT IS NOT IN THE (B)(6) INVENTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75757 GIRAFFE T-PIECE GIRAFFE T-PIECE BTL GE HEALTHCARE, LLC
    75758 PANDA T-PIECE PANDA T-PIECE BTL GE HEALTHCARE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1