BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER WATER

    MDR report key: 2851741 · Received November 29, 2012

    Report

    Report Number
    9611451-2012-00861
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 13, 2012
    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). (B)(6). METHOD: THE COMPLAINT CHAMBER WAS RETURNED TO THE MANUFACTURER AND VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION IDENTIFIED CLEAR RESIDUE ON THE TOP OF THE CHAMBER DOME. THE DOME WAS FOUND TO BE CRACKED IN 3 PLACES. ONE CRACK STRETCHED FROM THE BASE TOWARDS ONE PORT. TWO CRACKS STRETCHED ALONG THE BASE, ONE BETWEEN THE BRACKET AND ONE PORT, AND THE SECOND BELOW THE OTHER PORT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: WE ARE UNABLE TO DETERMINE THE ROOT CAUSE. ALTHOUGH RESIDUE WAS OBSERVED ON THE CHAMBER DOME, THERE IS NO INDICATION THAT THE CRACKS WERE CAUSED BY THIS. EVERY MR290 CHAMBER IS PRESSURE TESTED TO (B)(4) 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 CRACKS APPEARED AFTER SIX DAYS OF USE, INDICATING THE FAULT OCCURRED POST PRODUCTION. 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." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE WAS A CRACK ON THE MR290 VENTED AUTOFEED CHAMBER BETWEEN THE CHAMBER DOME AND BASE PLATE SIX DAYS AFTER USE. NO PATIENT CONSEQUENCE WAS REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED CHAMBER WATER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290 110615

    Patients

    Seq Age Sex Outcome Treatment
    1