BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVITA VENTILATOR

    MDR report key: 33712 · Received June 25, 1996

    Report

    Report Number
    MW1009365
    Event Type
    Injury
    Date Received
    June 25, 1996
    Date of Event
    June 6, 1996
    Report Date
    June 14, 1996
    Manufacturer
    DRAGER INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    VENTILATOR SUPPORTING PT'S RESPITATORY NEEDS BECAME DISCONNECTED (LOOSENED, BUT NOT COMPLETELY UNPLUGGED) FROM POWER SOURCE. INTERNAL VENTILATOR FAILURE AUDIBLE/VISUAL ALARMS NEVER ACTIVATED. CAREGIVER (RESPIRATORY THERAPIST) RECOGNIZED SITUATION IMMEDIATELY UPON VISUAL ASSESSMENT AND RECONNECTED VENTILATOR TO POWER AND SUPPORTED THE PT, FOLLOWED BY REMOVING THIS VENTILATOR FROM SERVICE. EQUIPMENT WAS RETURNED FROM MFR ON 5/21/96 WITH REPORT OF 'NO PROBLEMS' FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVITA VENTILATOR EVITA VENTILATOR CBK DRAGER INC. EVITA ARAF-0050 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Life Threatening| R