BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAGER E4

    MDR report key: 219174 · Received April 14, 1999

    Report

    Report Number
    MW1016142
    Event Type
    Injury
    Date Received
    April 14, 1999
    Date of Event
    April 10, 1999
    Report Date
    April 14, 1999
    Manufacturer
    DRAGER, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    VENTILATOR FAILED COMPLETELY WHILE ATTACHED TO PT. PT WAS REMOVED FROM THE VENTILATOR AND HAND BAGGED UNTIL ANOTHER VENTILATOR COULD BE SUBSTITUTED. PT DID NOT SUSTAIN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAGER E4 MECHANICAL VENTILATOR CBK DRAGER, INC. E4 *

    Patients

    Seq Age Sex Outcome Treatment
    1 29 DAY Required Intervention