BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRLIFE VENTILATOR MONITORING ADAPTER CIRCUIT

    MDR report key: 12366 · Received March 29, 1994

    Report

    Report Number
    MW1001293
    Event Type
    Injury
    Date Received
    March 29, 1994
    Report Date
    March 17, 1994
    Manufacturer
    PHARMASEAL DIV. BAXTER HEALTHCARE CORP.
    Product Code
    BZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON SEVERAL OCCASIONS, MEMBERS OF THE ANESTHESIA DEPT AND PACU HAVE PUT THIS ITEM TOGETHER ONLY TO FIND OUT THAT THE ONE-WAY VALVES INCORPORATED IN THIS ITEM WERE INSTALLED BACKWARDS PRECLUDING THE PT FROM RECEIVING PROPER, IF ANY, FRESH O2 FLOW. IN ONE INSTANCE, STAFF TRANSPORTED A PT TO ICU, NOT REALIZING THAT THEY HAD ASSEMBLED THIS EQUIPMENT INCORRECTLY AND PT RECEIVED NO SUPPLEMENTAL OXYGENATION. IN RPTR'S OPINION, IT IS FAR TOO EASY TO INADVERTENTLY MISASSEMBLE THIS ITEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AIRLIFE VENTILATOR MONITORING ADAPTER CIRCUIT MONITOR ADAPTER CIRCUIT BZO PHARMASEAL DIV. BAXTER HEALTHCARE CORP. F3N15001

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening| R