BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2803712 · Received October 25, 2012

    Report

    Report Number
    9611451-2012-00748
    Event Type
    Malfunction
    Date Received
    October 25, 2012
    Date of Event
    September 25, 2012
    Report Date
    September 25, 2012
    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). LOT NUMBER AND DEVICE MANUFACTURER DATE: 110813 - 08/13/2011, 120128 - 01/28/2012. METHOD: TWO COMPLAINT CHAMBERS WERE RECEIVED AND VISUALLY INSPECTED. RESULTS: THE CHAMBER DOME OF LOT 120128 APPEARED TO HAVE PULLED AWAY FROM THE BASE, BELOW ONE OF THE PORTS OF THE CHAMBER. THE VISUAL INSPECTION OF THE CHAMBER, LOT110813, DID NOT REVEAL ANY DAMAGE TO THE DOME OR BASE. THE DAMAGE OBSERVED ON THE DOME WAS THAT CAUSED BY THE CUSTOMER BY PUSHING THE FEEDSET SPIKE THROUGH THE CHAMBER DOME AND FLOAT. DUE TO THE DAMAGE CAUSED BY THE CUSTOMER TO THE RETURNED CHAMBER, WE ARE UNABLE TO PERFORM A LEAK TEST AND CONFIRM THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 120128 AND LOT 110813. CONCLUSION: THE HOSPITAL HAS INFORMED US THAT THE SUBJECT MR290 CHAMBERS WERE USED WITH A SIPAP VENTILATOR. THIS TYPE OF VENTILATOR IS CAPABLE OF PRODUCING PRESSURES IN EXCESS OF (B)(4). THE INTEGRITY OF THE CHAMBER CAN BE AFFECTED WHEN PRESSURES EXCEED (B)(4). 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 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 STATE THE FOLLOWING: "USE OF THE MR290 ABOVE THE MAXIMUM OPERATING PRESSURE [(B)(4)] 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". A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE HAS SINCE BEEN IN CONTACT WITH THE HOSPITAL TO RESOLVE THIS ISSUE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE WAS WATER LEAKAGE FROM THE BASE OF FOUR MR290 VENTED AUTOFEED CHAMBERS DURING USE WITH THE SIPAP MACHINE AND MR850 RESPIRATORY HUMIDIFIERS. THE HOSPITAL HAS REPORTED THAT THE MR850 RESPIRATORY HUMIDIFIERS WERE LOWERED TO INCREASE THE DISTANCE BETWEEN BAG AND CHAMBER. IT WAS FURTHER REPORTED THAT TWO OF THE FOUR COMPLAINT CHAMBERS HAVE BEEN DISCARDED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290 SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 MR850 RESPIRATORY HUMIDIFIER| SIPAP VENTILATOR