BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 1633339 · Received March 12, 2010

    Report

    Report Number
    9611451-2010-00135
    Event Type
    Death
    Date Received
    March 12, 2010
    Report Date
    February 12, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K033710
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). FISHER & PAYKEL HEALTHCARE ('FPH') REPRESENTATIVES FROM OUR REGIONAL OFFICE IN THE (B) (4) ARE WORKING CLOSELY WITH HOSPITAL STAFF TO GAIN A BETTER UNDERSTANDING OF THE CIRCUMSTANCES SURROUNDING THE INCIDENT, THE CARRY OUT TRAINING AS WELL AS ASSISTANCE WITH TROUBLESHOOTING. WE ARE CURRENTLY AWAITING A RESPONSE TO OUR INQUIRY TO ASSIST WITH OUR ROOT CAUSE ANALYSIS AND ARE NOT YET IN A POSITION TO PROVIDE AN OUTLINE OF OUR RESULTS AND CONCLUSION. FPH HAS SINCE BEEN ADVISED BY THE HOSPITAL THAT THE COMPLAINT HUMIDIFIER APPEARS TO BE FUNCTIONING CORRECTLY WITH NO FAULTS DETECTED FOLLOWING A PERFORMANCE TEST OF THE DEVICE. OUR UNDERSTANDING IS THAT THE DEVICE WAS RETURNED TO SERVICE AND TO THE BEST OF OUR KNOWLEDGE, IS OPERATING WITHOUT FURTHER INCIDENT. WE WILL SUBMIT OUR FINDINGS AND FURTHER COMMENTS IN OUR F/U / FINAL REPORT IN DUE COURSE.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B) (6) REPORTED THE FOLLOWING VIA A FISHER & PAYKEL ('FPH') REPRESENTATIVE: IN A SET-UP WHICH INCLUDED FPH'S MR850 RESPIRATORY HUMIDIFIER, VISION VENTILATOR, RESPIRONICS BREATHING CIRCUIT AND RESPIRONICS HUMIDIFICATION CHAMBER, IT WAS ALLEGED THAT CONDENSATE OCCURRED WITHIN THE RESPIRONICS BREATHING CIRCUIT. THE HOSPITAL ALLEGED THAT APPROXIMATELY 1CM OF WATER POOLED AT THE BOTTOM PORTION OF THE BREATHING CIRCUIT, IN THE REGION WHERE IT FORMED INTO A 'U' SHAPE OR BEND. FOLLOWING THE INITIAL NOTIFICATION OF THE INCIDENT, THE HOSPITAL LATER CONFIRMED THAT THE PT PASSED AWAY. NO DETAILS HAVE YET BEEN PROVIDED REGARDING THE CAUSE OF DEATH NOR THE EVENTS LEADING UP TO THE DEATH. FPH IS CURRENTLY IN THE PROCESS OF INVESTIGATING THE CIRCUMSTANCES SURROUNDING THE INCIDENT. FOLLOWING THE INCIDENT, THE MR850 RESPIRATORY HUMIDIFIER WAS PERFORMANCE TESTED BY AN ENGINEER AT THE HOSPITAL'S (B) (6) DEPARTMENT. THE HOSPITAL CONFIRMED THAT NO FAULT COULD BE FOUND WITH THE DEVICE.

    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 Death VISION VENTILATOR| RESPIRONICS HUMIDIFICATION CHAMBER (MODEL UNK)| RESPIRONICS BREATHING CIRCUIT (MODEL UNK)