BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 5309148 · Received December 17, 2015

    Report

    Report Number
    9611451-2015-00535
    Event Type
    Malfunction
    Date Received
    December 17, 2015
    Report Date
    November 20, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290 AUTOFEED HUMIDIFICATION CHAMBERS WERE RECEIVED TODAY AT FISHER & PAYKEL HEALTHCARE IN (B)(4). WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE TWO COMPLAINT MR290V CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN NEW (B)(4) AND WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT FOR BOTH COMPLAINT DEVICES, THE CHAMBER DOME WAS CRACKED. VISUAL INSPECTION OF DEVICE 1 REVEALED THAT THE DOME WAS CRACKED ALONG THE BASE, STARTING BELOW THE PORT AND ENDING BELOW THE BAFFLE. A SECOND CRACK WAS FOUND ABOVE THE BRACKET. RESIDUE WAS OBSERVED IN SEVERAL PLACES ON THE OUTER SURFACE OF THE CHAMBER DOME. FOR DEVICE 2, VISUAL INSPECTION REVEALED THAT THE CHAMBER DOME WAS ALSO CRACKED ALONG THE BASE, STARTING BELOW THE PORT AND ENDING BELOW THE BAFFLE. RESIDUE AND FLOW MARKS WERE ALSO OBSERVED IN SEVERAL PLACES ON THE OUTER SURFACE OF THE CHAMBER DOME. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 150727. CONCLUSION: THE RESIDUE FOUND ON THE CHAMBER DOMES INDICATES THAT THE CHAMBERS CAME IN CONTACT WITH A SOLUTION CONTAINING ALCOHOL WHICH RESULTED IN ENVIRONMENTAL STRESS CRACKING OF THE CHAMBER DOMES. EVERY MR290 CHAMBER IS PRESSURE TESTED 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. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER STATE THE FOLLOWING: DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS. SET APPROPRIATE VENTILATOR ALARMS. PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT TWO MR290V HUMIDIFICATION CHAMBERS WERE LEAKING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT TWO MR290V HUMIDIFICATION CHAMBERS WERE LEAKING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834190 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 150727

    Patients

    Seq Age Sex Outcome Treatment
    1