BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARE FUSION

    MDR report key: 2887593 · Received December 17, 2012

    Report

    Report Number
    MW5028305
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    December 13, 2012
    Report Date
    December 17, 2012
    Manufacturer
    CARE FUSION
    Product Code
    CBK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    RT IN REACHING FOR PRODUCTS, BUMPED THE SIDE OF THE VENT, IT THEN POWERED OFF; SCREEN BLACK AND NO VENTILATION CYCLING. AT 0830 PT HAD "LOW MINUTE VENTILATION" VOLUME ALARM WHILE ON FOLLOWING SETTINGS; C-PAP 7, PRESSURE SUPPORT 14, FIO2 AT 28 PERCENT. RCP TOOK PT OFF VENT, BAGGED ADN SUCTIONED FOR O2 SAT OF 89%. PUT BACK ON VENT FOR APPROXIMATELY 15-30 SECS. PT O2SAT AT THAT TIME DROPPED TO 77%, WHEN VENT TURNED OFF. SECOND RT BEGAN BAGGING PT AND O2 SATS WENT TO 99% 0900 NEW VENTILATOR PLACED ON PT NEW SETTINGS VOLUME SIMV RR 14, TIDAL VOLUME 600, PEEP 5, PS 14 FIO 28%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARE FUSION VENTILATOR CBK CARE FUSION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR