BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2242551-1996-00008

    MDR report key: 43844 · Received October 15, 1996

    Report

    Report Number
    2242551-1996-00008
    Event Type
    Injury
    Date Received
    October 15, 1996
    Date of Event
    September 11, 1996
    Report Date
    September 13, 1996
    Product Code
    BTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report

    Narratives

    Description of Event or Problem · 1

    AN INFANT RESUSCITATION SUPPORT DEVICE WAS TAKEN OUT OF ITS PLASTIC CONTAINER AND MADE READY FOR USE ON AN ADULT PT. WHEN USED IT CAUSED MAJOR COMPLICATIONS. THE PT HAD TO BE TREATED FOR A TENSION PNEUMOTHORAX. IT WAS FOUND THAT THE BAG PORTION OF THE DEVICE WAS INSERTED INTO THE TUBING BACKWARDS (VALVE END).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BTM

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention