BEUDAMED
    FDA Adverse Event Death Summary report: N

    MICROVENT

    MDR report key: 134141 · Received November 19, 1997

    Report

    Report Number
    9611500-1997-00011
    Event Type
    Death
    Date Received
    November 19, 1997
    Date of Event
    September 27, 1997
    Report Date
    November 19, 1997
    Manufacturer
    DRAGER MEDIZINTECHNIK GMBH
    Product Code
    CBK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WAS INTENSIVELY INVESTIGATED BY DRAGER MEDIZINTECHNIK GMBH. A DEFECT OF THE INSPIRATION/EXPIRATION VALVE CAUSED A MALFUNCTION OF THE DEVICE. AN AUDIBLE AND VISIBLE ALARM WAS GENERATED BY THE DEVICE BASED ON THE DEFECTIVE VALVE. THE USER DID NOT REACT IN ACCORDANCE TO THE USER MANUAL. IT REQUIRES TO START WITH MANUAL VENTILATION IF AN MALFUNCTION IS INDICATED BY THE DEVICE. THE SAFETY CONCEPT OF THE VENTILATOR IS STATE OF THE ART, THE DEFECTIVE VALVE WAS DISCOVERED BY THE DEVICE AND THE ALARM WAS GENERATED. ONLY ONE OTHER COMPLAINT CONCERNING A DEFECT OF THE VALVE IS IN CO'S COMPLAINT FILE. THEREFORE THAT LIKELIHOOD OF REOCCURRENCE IS MINIMAL AND NO FURTHER ACTIONS ARE NECESSARY. THE DEVICE WAS REPAIRED, TESTED ACCORDING TO THE INSPECTION PLAN AND SENT BACK TO THE CUSTOMER IN INDIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASB-FUNCTION WAS NOT FUNCTIONING AND THAT THE MINUTE VOLUME ALARM WAS NOT GENERATED. IT WAS ALSO REPORTED THAT THE PT DIED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death