BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 1002627 · Received February 27, 2008

    Report

    Report Number
    9611451-2008-00069
    Event Type
    Death
    Date Received
    February 27, 2008
    Date of Event
    January 27, 2008
    Report Date
    January 28, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN QUARANTINED BY THE HOSP. RESULTS: RESPIRONICS ESPRIT VENTILATOR. CONCLUSIONS: THE HOSP CONTINUED TO USE THE RT110 ADULT BREATHING CIRCUIT WITH THE RESPIRONICS ESPRIT VENTILATOR CONTRARY TO FISHER & PAYKEL HEALTHCARE RECOMMENDATIONS. WE ARE CONTINUING TO INVESTIGATE THIS REPORTED EVENT AND SEEK ADD'L INFO FROM THE REPORTING HOSP.

    Description of Event or Problem · 1

    A HOSP REPORTED TO OUR DIST THAT "ONE PT CODED AND EVENTUALLY EXPIRED" WHILST ON A RESPIRONICS ESPRIT VENTILATOR, FISHER & PAYKEL HEALTHCARE MR850 RESPIRATORY HUMIDIFIER AND THE RT110 ADULT BREATHING CIRCUIT. F/U INFO FROM THE HOSP INCLUDED: THE HOSP BEGAN USING DUAL HEATED BREATHING CIRCUITS "IN 2007, AND THEY HAD BEEN EXPERIENCING CONDENSATE ISSUES IN THEIR VENTILATOR SYSTEMS. IN 2008, A MALE PT "CODED" AND THE HOSP ATTEMPTED TO RESUSCITATE THE PT FOR APPROX 30 MINS "WITHOUT SUCCESS". THE "VENTILATOR DID ALARM" AND THE "NURSE THAT DISCOVERED IT SAW 'OCCLUSION' IN THE WINDOW" OF THE VENTILATOR. THE HOSP IS CURRENTLY IN POSSESSION OF THE VENTILATOR AND HUMIDIFIER. THE PRIOR STATUS OF THE PT IS UNK. IT SHOULD BE NOTED THAT THE HOSP CONTINUED TO USE THE RT110 ADULT BREATHING CIRCUIT WITH THE RESPIRONICS ESPRIT VENTILATOR CONTRARY TO FISHER & PAYKEL HEALTHCARE RECOMMENDATIONS. THE VENTILATOR MFR HAS BEEN NOTIFIED OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR850

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death RESPIRONICS ESPRIT VENTILATOR| BREATHING CIRCUIT| FISHER & PAYKEL HEALTHCARE RT110 ADULT