BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIS

    MDR report key: 7068974 · Received November 29, 2017

    Report

    Report Number
    2936999-2017-05641
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Report Date
    November 29, 2017
    Manufacturer
    ASPECT MEDICAL
    Product Code
    GWS
    PMA / PMN Number
    K072286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE UNIT SHOWED THAT PATIENT WAS AWAKE WHEN PATIENT WAS CLEARLY ASLEEP. THERE WAS NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849004 BIS ANALYZER, SPECTRUM, ELECTROENCEPHALOGRAM SIGNAL GWS ASPECT MEDICAL 186-1046

    Patients

    Seq Age Sex Outcome Treatment
    1