BEUDAMED
    FDA Adverse Event Death Summary report: N

    VITAL SIGNS, INC.

    MDR report key: 10293 · Received October 20, 1993

    Report

    Report Number
    10293
    Event Type
    Death
    Date Received
    October 20, 1993
    Date of Event
    October 9, 1993
    Report Date
    October 19, 1993
    Manufacturer
    VITAL SIGNS, INC.
    Product Code
    BYE
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS RECEIVING 100% O2 VIA A VITAL SIGNS "DOWN'S FLOWGENERATOR" AND AEROSOL MASK. PT WAS INTUBATED AND CONNECTED TO VITAL SIGNS 7.5 CMH2O CPAP VALVE (PART #9007). PT IMMEDIATELY ARRESTED WITH DEVELOPMENT OF SUB-Q EMPHYSEMA. CPAP VALVE DISCOVERED TO BE PLACED "IN-LINE" BACKWARDS USING A COMMON 22 MM OUTER DIAMETER ADAPTER. THIS PREVENTED THE PT FROM EXHALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAL SIGNS, INC. 7.5 CM H2O DOWN'S CPAP VALVE BYE VITAL SIGNS, INC. 9007

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death