BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1984378 · Received February 10, 2011

    Report

    Report Number
    9611451-2011-00069
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 13, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    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 COMPLAINT CHAMBER WAS VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION REVEALED THAT THE COMPLAINT CHAMBER DOME HAD BEEN COME AWAY FROM THE BASE ON ONE SIDE OF THE CHAMBER. A LOT CHECK REVEALED ONE OTHER SIMILAR COMPLAINT OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: AN ATTEMPT TO OBTAIN FURTHER INFORMATION WITH REGARD TO SET UP AND VENTILATOR PRESSURE SETTINGS HAS BEEN UNSUCCESSFUL. WE ARE UNABLE TO DETERMINE THE ROOT CAUSE, HOWEVER THE HOSPITAL HAS FURTHER REPORTED THAT THE CHAMBER WAS USED WITH A SIPAP VENTILATOR THAT IS CAPABLE OF PRODUCING PRESSURES IN EXCESS OF 80CMH2O. THE INTEGRITY OF THE CHAMBER CAN BE AFFECTED WHEN PRESSURES EXCEED 80CMH2O. OUR USER INSTRUCTIONS STATE: "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". ALL MR290 CHAMBERS ARE PRESSURE TESTED AND VISUALLY INSPECTED PRIOR TO DISTRIBUTION. THESE TESTS CHECK FOR PHYSICAL DAMAGE AND LEAKS. ANY CHAMBER WHICH FAILS THE PRESSURE TESTING OR VISUAL INSPECTION IS REJECTED. NO CONSEQUENCE TO THE PATIENT WAS REPORTED AS A RESULT OF THIS INCIDENT. THE HOSPITAL HAS REPORTED THE PATIENT TO BE WELL. OUR MONITORING AND TRENDING OF COMPLAINTS INVOLVING BASE LEAKS IN MR290 CHAMBERS HAS A RATE OF OCCURRENCE OF (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). WE HAVE RECENTLY RECEIVED THE COMPLAINT DEVICE AND ARE CURRENTLY CARRYING OUT AN INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE WAS WATER LEAKAGE FROM THE BASE OF AN MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBER DURING USE ON A BABY. THE HOSPITAL FURTHER REPORTED THAT THERE APPROXIMATELY 300ML OF WATER SPILLED ON THE GROUND. A BACK UP MACHINE WAS ALREADY SET UP AND WAS IMMEDIATELY PUT TO USE. THE PATIENT IS WELL AND SUFFERED NO CONSEQUENCES.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE WAS WATER LEAKAGE FROM THE BASE OF AN MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBER DURING USE ON A BABY. THE HOSPITAL FURTHER REPORTED THAT THERE APPROXIMATELY 300ML OF WATER SPILLED ON THE GROUND. A BACK UP MACHINE WAS ALREADY SET UP AND WAS IMMEDIATELY PUT TO USE. THE PATIENT IS WELL AND SUFFERED NO CONSEQUENCES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1