BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 3395601 · Received October 8, 2013

    Report

    Report Number
    9611451-2013-00788
    Event Type
    Malfunction
    Date Received
    October 8, 2013
    Date of Event
    August 29, 2013
    Report Date
    September 10, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290 CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4). THE CHAMBER WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A CRACK IN THE DOME STRETCHING ALONG THE BASE, BELOW ONE OF THE CHAMBER PORTS. THERE WAS ALSO A STRESS MARK ON THE CHAMBER DOME TO THE RIGHT OF THE CRACK. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 130403. CONCLUSION: WE WERE UNABLE TO DETERMINE THE ROOT CAUSE OF THE DAMAGE FOUND ON THE RETURNED CHAMBER. IT IS KNOWN THAT PRESSURES PRODUCED IN EXCESS OF 80 CMH20 (8 KPA) MAY AFFECT THE INTEGRITY OF THE CHAMBER. EVERY MR290 CHAMBER IS PRESSURE TESTED TO 200 CMH2O FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. ANY CHAMBER WHICH FAILS THIS TEST IS REJECTED. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. THE CUSTOMER HAS REPORTED THAT THE CRACK APPEARED AFTER TWO WEEKS OF USE, INDICATING THE FAULT OCCURRED AFTER THE CHAMBER WAS RELEASED FOR DISTRIBUTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER STATE THE FOLLOWING: - SET APPROPRIATE VENTILATOR ALARMS. - PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT. - MAXIMUM OPERATING PRESSURE: 8 KPA. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT AN MR290V HUMIDIFICATION CHAMBER LEAKED AT THE CONNECTION BETWEEN THE BASE PLATE AND THE DOME AFTER TWO WEEKS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509753 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 130403

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL RT206 BREATHING CIRCUIT