BEUDAMED
    FDA Adverse Event Death Summary report: N

    BCI

    MDR report key: 230136 · Received July 2, 1999

    Report

    Report Number
    230136
    Event Type
    Death
    Date Received
    July 2, 1999
    Date of Event
    June 24, 1999
    Report Date
    June 29, 1999
    Manufacturer
    BCI INTERNATIONAL
    Product Code
    DQA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WITNESSED RESPIRATORY ARREST DURING CARDIAC TRIAL; CARDIAC ARREST PER CRASH CART MONITOR. ALARM CONNECTED THROUGH VENT FAILED TO ACTIVATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BCI PULSE OXIMETER DQA BCI INTERNATIONAL 71200A1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death