BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1977257 · Received February 2, 2011

    Report

    Report Number
    9611451-2011-00053
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Report Date
    January 6, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE SAMPLE CHAMBER (LOT NUMBER 100402) WAS PRESSURE TESTED AND SUBMERGED IN A WATER BATH TO CHECK FOR LEAKS. THE CHAMBER WAS ALSO VISUALLY INSPECTED FOR DAMAGE. RESULTS: PRESSURE TESTING REVEALED THAT THE CHAMBER WAS LEAKING, CONFIRMING THE REPORTED FAULT. SUBMERSION OF THE CHAMBER IN A WATERBATH SHOWED THAT THE LEAK WAS EVENLY SPREAD AROUND THE SEAL BETWEEN THE CHAMBER DOME AND THE CHAMBER BASE. THE CHAMBER DOME WAS FOUND TO HAVE WHITE STRESSMARKS AROUND THE BASE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100402. CONCLUSION: THE COMPLAINT CHAMBER WAS FOUND TO BE LEAKING AT THE SEAL BETWEEN THE CHAMBER DOME AND CHAMBER BASE. STRESS MARKS WERE FOUND AT THE BASE OF THE CHAMBER DOME. ALL MR290 CHAMBERS ARE PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS. THIS PRESSURE TEST CHECKS FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. ANY CHAMBER WHICH FAILS THIS TEST IS REJECTED. AFTER THE PRESSURE TEST, A VISUAL INSPECTION OF EACH CHAMBER IS ALSO PERFORMED. THIS SUGGESTS THAT THE DOME WAS DAMAGED AND DEVELOPED A LEAK POST-PRODUCTION, HOWEVER WE WERE UNABLE TO DETERMINE THE ROOT CAUSE OF THIS FAULT. THE MR290 USER INSTRUCTIONS ADVISE THE USER TO "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM BEFORE CONNECTING TO A PATIENT" AND TO "SET THE APPROPRIATE VENTILATOR ALARMS" TO ALERT THEM OF ANY LEAKS IN THE SYSTEM.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE SAMPLE CHAMBER HAS BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE'S REGIONAL OFFICE AND SERVICE CENTER IN (B)(4). THE CHAMBER IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT SIX MR290 AUTOFILL HUMIDIFICATION CHAMBERS LEAKED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT SIX MR290 AUTOFILL HUMIDIFICATION CHAMBERS LEAKED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290 100402 (1), NOT PROVIDED (5)

    Patients

    Seq Age Sex Outcome Treatment
    1