BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3865641 · Received June 11, 2014

    Report

    Report Number
    9611451-2014-00499
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Report Date
    May 13, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE TWO COMPLAINT CHAMBERS WERE RECEIVED AT FISHER & PAYKEL HEALTHCARE (B)(4). ONE CHAMBER WAS FROM LOT 130424, MANUFACTURED 24 APR 2013. THE SECOND CHAMBER WAS FROM LOT 130816, MANUFACTURED 16 AUG 2013. BOTH CHAMBERS WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE CHAMBER DOMES WERE CRACKED NEAR THE BAFFLE. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR EITHER LOT NUMBER. CONCLUSION: THE NATURE OF THE CRACKING IS CONSISTENT WITH THE CHAMBERS BEING USED WITH A SIPAP VENTILATOR. THIS TYPE OF VENTILATOR 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 CHAMBERS WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290 STATE 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. PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT WATER LEAK OCCURRED FROM TWO MR290 AUTOFEED CHAMBERS. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344332 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 130424

    Patients

    Seq Age Sex Outcome Treatment
    1