BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSA4000

    MDR report key: 636248 · Received September 19, 2005

    Report

    Report Number
    1224640-2005-00001
    Event Type
    Injury
    Date Received
    September 19, 2005
    Report Date
    August 22, 2005
    Manufacturer
    PHYSIOMETRIX, INC.
    Product Code
    GWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CLINICIAN GAVE REPEATED DOSES OF VERSED (45 MG TOTAL) IN RESPONSE TO HIGH PSI VALUES DURING THE COOLING PHASE OF CARDIAC SURGERY. AS A RESULT OF THE EXCESSIVE DOSESOF VERSED PT HAD PROLONGED STAY (3 DAYS) IN THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSA4000 EEG MONITOR GWQ PHYSIOMETRIX, INC. 4000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization