BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE OXIMETER

    MDR report key: 19402 · Received February 3, 1995

    Report

    Report Number
    MW1005009
    Event Type
    Injury
    Date Received
    February 3, 1995
    Date of Event
    January 18, 1995
    Report Date
    January 26, 1995
    Manufacturer
    BCI INTL., INC.
    Product Code
    DQA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    DEVICE QUITS WORKING COMPLETELY, SPONTANEOUSLY. CAME ON SOMETIME LATER WITH ALARM SILENCED (AS IS NORMAL WHEN IT IS FIRST TURNED ON). THIS HAPPENED AT SAME TIME PT HAD RESPIRATORY EMERGENCY. MACHINE DID NOT ALARM TO ALERT CAREGIVERS, SO THEY WERE UNABLE TO RESPOND AS QUICKLY AS THEY COULD HAVE. PT TURNED VERY BLUE WITH INCREASE HR AND BP. THIS SHUTTING OFF AND COMING BACK ON HAPPENED 2-3 TIMES OVER THE NEXT 1-2 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE OXIMETER PULSE OXIMETER DQA BCI INTL., INC. 3040

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Life Threatening| R