BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2152899 · Received July 7, 2011

    Report

    Report Number
    9611451-2011-00409
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 9, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED MR290V WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: VISUAL INSPECTION OF THE RETURNED CHAMBER REVEALED THAT THE CHAMBER DOME HAS BEEN PULLED AWAY FROM THE BASE ON ONE SIDE OF THE CHAMBER. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100911. CONCLUSION: WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE DAMAGE OBSERVED; HOWEVER, THE HOSPITAL HAS FURTHER REPORTED THAT THE CHAMBER WAS USED WITH A SIPAP VENTILATOR, WHICH IS CAPABLE OF PRODUCING PRESSURES IN EXCESS OF 80CMH2O. THE INTEGRITY OF THE CHAMBER CAN BE AFFECTED WHEN PRESSURES EXCEED 80CMH2O. EVERY MR290 CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. ANY CHAMBER WHICH FAILS EITHER OF THESE TESTS IS REJECTED. THE SUBJECT CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THIS SUGGESTS THE CHAMBER WAS DAMAGED POST PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290 STATES THE FOLLOWING: "USE OF THE MR290 ABOVE THE MAXIMUM OPERATING PRESSURE [8KPA (~80CMH2O)] MAY LEAD TO CRACKING, WATER LEAKAGE AND, ON RARE OCCASIONS COULD LEAD TO A LOSS OF VENTILATION PRESSURE." "SET APPROPRIATE VENTILATOR ALARMS." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSION BEFORE CONNECTING TO A PATIENT." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE BASE OF AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER LEAKED WHILE BEING USED ON A PATIENT. IT WAS FURTHER REPORTED THAT THE BASE "APPEARS TO HAVE BEEN PULLED AWAY FROM THE HEATER PLATE." NO PATIENT CONSEQUENCE WAS REPORTED AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 100911

    Patients

    Seq Age Sex Outcome Treatment
    1