BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGER

    MDR report key: 105033 · Received July 1, 1997

    Report

    Report Number
    105033
    Event Type
    Injury
    Date Received
    July 1, 1997
    Date of Event
    April 10, 1997
    Report Date
    June 12, 1997
    Manufacturer
    DRAGER, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    VENT SETTINGS: RATE 12 PC AND PS (SIMV) VT 750 FLOW FIO2 FI02 50%. ALARMS LO/HIGH VE 5/20. WITNESSED POWER FAILURE IN VENT. LEDS WENT OFF AND RESPIRATIONS CEASED FOR FEW SECONDS. WITHOUT INTERVENTION VENT CAME BACK ON, RESUMED OPERATION AND ALARMED LOW MINUTE VOLUME. NO OTHER ERROR MESSAGE. VENT CONTINUED TO OPERATE AND LOW MINUTE VOLUME ALARM STOPPED ONCE PT RATE REACHED SET VALUE SOMETIME AFTER AND DID NOT COME BACKED ON. PT REQUIRED BAGGING. NO OTHER INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAGER EVITZ VENTILATOR CBK DRAGER, INC. EVITA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Life Threatening| R