BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2226203 · Received August 29, 2011

    Report

    Report Number
    9611451-2011-00529
    Event Type
    Malfunction
    Date Received
    August 29, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 6, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED MR290VX CHAMBER WAS VISUALLY INSPECTED FOR CRACKS. RESULTS: VISUAL INSPECTION REVEALED THAT THE CHAMBER WAS CRACKED AT THE BASE OF THE DOME. THE CRACK STARTED NEXT TO THE BRACKET AND STRETCHED TOWARDS THE BAFFLE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110406. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM OBSERVED BY THE HOSPITAL. HOWEVER, IT IS MOST LIKELY RELATED TO DAMAGE FROM TRANSPORTATION OR STORAGE OF THE DEVICE AS THE FAULT WAS DETECTED SHORTLY AFTER THE HOSPITAL STARTED TO USE THE CHAMBER. EVERY MR290 CHAMBER IS PRESSURE TESTED TO 200CMH20 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. THIS SUGGESTS THAT THE CRACKS OCCURRED POST PRODUCTION. FISHER & PAYKEL HEALTHCARE'S USER INSTRUCTIONS THAT ACCOMPANY THE MR290 CHAMBER SPECIFY TO THE USER TO "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM BEFORE CONNECTING TO A PATIENT", TO REFRAIN FROM USING THE CHAMBER IF IT HAS BEEN DROPPED AND "TO SET THE APPROPRIATE VENTILATOR ALARMS" IN THE EVENT A LEAK OCCURS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT WATER LEAKED AT THE BOTTOM OF THE MR290VX VENTED AUTOFEED HUMIDIFICATION CHAMBER. THIS WAS NOTICED AFTER THE CHAMBER WAS CONNECTED TO A WATER BOTTLE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290VX 110406

    Patients

    Seq Age Sex Outcome Treatment
    1