BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2212408 · Received August 15, 2011

    Report

    Report Number
    9611451-2011-00490
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 20, 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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER VISUALLY INSPECTED FOR CRACKS. THE HOSPITAL HAS REPORTED THAT THEY WERE USING THE INFANT FLOW SIPAP VENTILATOR. RESULTS: A VISUAL INSPECTION REVEALED THAT THE MR290 CHAMBER DOME WAS CRACKED ALONG THE BASE BUT NO STRESS MARKS WERE OBSERVED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110110. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM OBSERVED BY THE HOSPITAL. HOWEVER, IT IS UNLIKELY THAT THE CRACKS TO THE CHAMBERS WERE PRESENT AT THE TIME OF PRODUCTION. 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 CRACK 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 FROM THE CONNECTION BETWEEN THE CHAMBER DOME AND THE BASE PLATE OF AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER, WHEN THE BREATHING SYSTEM WAS CONNECTED TO THE INFANT FLOW SIPAP VENTILATOR. THIS WAS NOTICED DURING USE ON A PATIENT. 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 MR290V 110110

    Patients

    Seq Age Sex Outcome Treatment
    1 RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT