BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2208500 · Received August 11, 2011

    Report

    Report Number
    9611451-2011-00484
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    July 13, 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). THE COMPLAINT (B)(4) VENTED AUTOFEED HUMIDIFICATION CHAMBER VISUALLY INSPECTED. A VISUAL INSPECTION REVEALED THAT THE (B)(4) CHAMBER WAS CRACKED AT THE BASE OF THE DOME. THE TWO CRACKS WERE FOUND NEAR THE BRACKET AND ONE OF IT WAS STRETCHED FOR ABOUT 17MM. BOTH CRACKS HAD NO STRESS MARKS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110413. 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 (B)(4) CHAMBER IS PRESSURE TESTED (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. THIS SUGGESTS THAT THE CRACKS OCCURRED POST PRODUCTION. FISHER & PAYKEL HEALTHCARE'S USER INSTRUCTIONS THAT ACCOMPANY THE (B)(4) 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 SIDE OF AN (B)(4) VENTED AUTOFEED HUMIDIFICATION CHAMBER WHEN THE BREATHING CIRCUIT SYSTEM WAS CONNECTED TO AN INFANT LOW FLOW SIPAP. 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 110413

    Patients

    Seq Age Sex Outcome Treatment
    1 INFANT LOW FLOW SIPAP| INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT