BEUDAMED
    FDA Adverse Event Death Summary report: N

    BIPAP S/T VENTILATORY SUPPORT SYSTEM

    MDR report key: 307936 · Received December 11, 2000

    Report

    Report Number
    2518422-2000-00054
    Event Type
    Death
    Date Received
    December 11, 2000
    Date of Event
    November 10, 2000
    Report Date
    December 8, 2000
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    UNIT WAS BEING USED IN THE HOSP ICU. OXYGEN WAS BEING BLED INTO THE PT CIRCUIT THROUGH A TEE-CONNECTOR AT THE OUTLET OF THE BIPAP. THE HOSP REPORTED THAT THE STAFF SAW SMOKE COME FROM THE UNIT.

    Description of Event or Problem · 1

    UNIT WAS BEING USED IN THE HOSP ICU. OXYGEN WAS BEING BLED INTO THE PT CIRCUIT THROUGH A TEE-CONNECTOR AT THE OUTLET OF THE BIPAP. THE HOSP REPORTED THAT THE STAFF SAW SMOKE COME FROM THE UNIT.

    Description of Event or Problem · 1

    HOSPITAL REPORTED THAT A DEVICE CAUGHT FIRE WHILE BEING DEMONSTRATED AND ONE PT HAS EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIPAP S/T VENTILATORY SUPPORT SYSTEM NON CONTINUOUS VENTILATOR BZD RESPIRONICS, INC. 552045 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death