BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFE PULSE PATIENT BREATHING CIRCUIT

    MDR report key: 238139 · Received August 27, 1999

    Report

    Report Number
    1719232-1999-00011
    Event Type
    Other
    Date Received
    August 27, 1999
    Manufacturer
    BUNNELL, INC.
    Product Code
    LSZ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    USER REPORTED OVERFILL OF THE HUMIDIFIER CIRCUIT. WATER ENTERED THE PT LINE AND WAS DELIVERED TO THE PT. THE PT WAS SUCTIONED AND WAS NOT HARMED BY THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE PULSE PATIENT BREATHING CIRCUIT VENTILATOR ACCESSORY LSZ BUNNELL, INC. NA 9C0102, 9E0147

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention