BEUDAMED
    FDA Adverse Event Other Summary report: N

    FISHER PAYKEL

    MDR report key: 187637 · Received September 17, 1998

    Report

    Report Number
    MW4002255
    Event Type
    Other
    Date Received
    September 17, 1998
    Date of Event
    July 27, 1998
    Report Date
    August 21, 1998
    Manufacturer
    FISHER PAYKEL HEALTHCARE, INC.
    Product Code
    BTT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    VENTILATOR SET ON "PCV" RATE 16, PULSE OUTPUT - 26, PEAK INSPIRATORY PRESSURE 31, BASELINE 14, ITEM 20, FORCED INSPIRATION 02 100%. PT ON NEMBEX. OXYGEN SATS DETERIORATED TO 85. IN THE PT MONITORING SECTION OF THE VENTILATOR THE RESPIRATORY RATE READ, 28 AND SPONTANEOUS RESPIRATORY RATE READ 0. THE SYSTEM WAS CHECKED FOR LEAKS SINCE THE THERAPIST FELT THE MACHINE WAS AUTO CYCLING BUT COULD NOT DETERMINE THE CAUSE. THE VENTILATOR WAS CHANGED TO A HAMILTON VEOLAR & THE FREQUENCY WAS INCREASED TO 18. MONITORED PEAK INSPIRATORY PRESSURE WAS 36, VT WAS 720 AND VOLUME EXPIRED WAS 11.4. OXYGEN SATS IMPROVED TO 97. THE VENTILATOR WAS CHECKED BY BIOMED & A CRACK WAS FOUND ON THE BACK SIDE OF THE FISHER PAYKEL HUMIDIFICATION CHAMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FISHER PAYKEL HUMIDIFICATION CHAMBER BTT FISHER PAYKEL HEALTHCARE, INC. MR 290 EU 97280

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other