BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIFICATION CHAMBERS

    MDR report key: 2117448 · Received June 9, 2011

    Report

    Report Number
    9611451-2011-00333
    Event Type
    Malfunction
    Date Received
    June 9, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).METHOD: TWO COMPLAINT CHAMBERS, WITH LOT NUMBERS 101129 AND 110211, WERE RETURNED AND VISUALLY INSPECTED.RESULTS: THE VISUAL INSPECTION REVEALED THE COMPLAINT CHAMBER WITH LOT NUMBER 101129 HAD CRACKED IN SEVERAL PLACES. ONE CRACK WAS OBSERVED UNDERNEATH THE BRACKET A LONG THE BASE. SEVEN CRACKS WERE IDENTIFIED BETWEEN THE BRACKET AND THE BAFFLE, STARTING FROM THE BASE OF THE CHAMBER AND VERTICALLY UP TOWARDS THE WATER LEVEL MARK. NONE OF THE CRACKS SHOW ANY STRESSMARKS.THE VISUAL INSPECTION OF THE COMPLAINT CHAMBER WITH LOT NUMBER 110211 REVEALED A CRACK ALONG THE BASE OF THE CHAMBER DOME AND ONE ABOVE THE BRACKET. NO STRESSMARKS WERE OBSERVED AROUND THE CRACKS.A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 101129.A LOT CHECK REVEALED ONE OTHER COMPLAINTS OF SIMILAR NATURE FOR LOT NUMBER 110211.CONCLUSION: WE WERE UNABLE TO DETERMINE THE PROBLEM OBSERVED BY THE CUSTOMER. HOWEVER, IT IS UNLIKELY THAT THE CRACKS WERE PRESENT AT THE TIME OF PRODUCTION. ALL MR290 CHAMBERS ARE PRESSURE TESTED AND VISUALLY INSPECTED PRIOR TO DISTRIBUTION. THESE TESTS CHECK FOR PHYSICAL DAMAGE AND LEAKS, ANY CHAMBER WHICH FAILS THE PRESSURE TESTING OR VISUAL INSPECTION IS REJECTED. THIS SUGGESTS THAT THE CRACKS OCCURRED POST-PRODUCTION.OUR USER INSTRUCTIONS STATE:"USE OF THE MR290 ABOVE THE MAXIMUM OPERATING PRESSURE [8KPA (~80CMH2O)] MAY LEAD TO CRACKING, WATER LEAKAGE AND, ONRARE OCCASIONS COULD LEAD TO A LOSS OF VENTILATION PRESSURE"."SET APPROPRIATE VENTILATOR ALARMS"."PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSION BEFORE CONNECTING TO A PATIENT"."DO NOT USE THE CHAMBER IF THE SEALS ARE NOT INTACT WHEN RECEIVED, OR IF IT HAS BEEN DROPPED".

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE, (B)(4). WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE WAS WATER LEAKAGE FROM TWO MR290 VENTED AUTOFEED HUMIFICATION CHAMBERS WHILE IN USE WITH AN RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE WAS WATER LEAKAGE FROM TWO MR290 VENTED AUTOFEED HUMIFICATION CHAMBERS WHILE IN USE WITH AN RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT.NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIFICATION CHAMBERS BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 110211, 101129

    Patients

    Seq Age Sex Outcome Treatment
    1 BABYLOG 8000 VENTILATOR