BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICROVENT

    MDR report key: 304958 · Received November 17, 2000

    Report

    Report Number
    9611500-2000-00016
    Event Type
    Death
    Date Received
    November 17, 2000
    Date of Event
    October 5, 2000
    Report Date
    November 16, 2000
    Manufacturer
    DRAGER MEDIZINTECHNIK GMBH
    Product Code
    CBK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR WAS USED FOR NON-INVASIVE VENTILATION AND THAT THE PT BECAME BLUE. IT WAS FURTHER REPORTED THAT THE PT WAS "INTUBED", THAT THE VENTILATOR DID NOT DELIVER ANY GAS AND THAT NO ALARM WAS GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROVENT VENTILATOR CONTINUOUS CBK DRAGER MEDIZINTECHNIK GMBH MICROVENT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death