BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PURITAN-BENNETT

    MDR report key: 115392 · Received July 28, 1997

    Report

    Report Number
    115392
    Event Type
    Injury
    Date Received
    July 28, 1997
    Date of Event
    May 25, 1997
    Report Date
    May 29, 1997
    Manufacturer
    PURITAN-BENNETT
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    WHEN PT PLACED ON VENTILATOR, SP02 WOULD DECREASE BY 20-30%. WHEN GRAPHICS WERE USED, PT. WOULD GET TWO SIMV BREATHS THEN A PRESSURE SUPPORT BREATH WHICH WOULD SET "LPK" 2 SECONDS WITH A CORRESPONDING TV OF GREATER THAN 7.0 LITERS. NO LEAK FOUND. PT BAGGED. VENTILATOR CHANGED OUT. PT'S SP02 INCREASED FROM 75% TO 95% IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PURITAN-BENNETT VENTILATOR CBK PURITAN-BENNETT 7200 *

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention