BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 4400989 · Received January 8, 2015

    Report

    Report Number
    9611451-2015-00017
    Event Type
    Malfunction
    Date Received
    January 8, 2015
    Date of Event
    December 8, 2014
    Report Date
    December 11, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    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 CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE THEY WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF BOTH CHAMBERS REVEALED CRACKS AND CRAZING PATTERN ON THE CHAMBER DOMES. RESIDUE WAS ALSO NOTED ON BOTH CHAMBERS. STRESS MARKS WERE NOTED ON ONE CHAMBER WHILE THE PRINT ON THE OTHER CHAMBER WAS SMEARED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 140717. CONCLUSION: BASED ON THE INSPECTION CARRIED OUT, IT IS LIKELY THAT THE DAMAGE WAS CAUSED BY THE CHAMBERS COMING INTO CONTACT WITH A SOLUTION CONTAINING ETHANOL/ALCOHOL RESULTING 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. THIS SUGGESTS THAT THE RETURNED CHAMBERS WERE DAMAGED AFTER THEY WERE RELEASED FOR DISTRIBUTION. THE CUSTOMER ONLY REPORTED THE CRACKING AFTER THREE DAYS OF USE. 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. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6). REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT WATER LEAKED FROM TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS AFTER THREE DAYS OF USE. THEY FURTHER REPORTED CRACKS ON BOTH CHAMBERS. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18620 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1407170304

    Patients

    Seq Age Sex Outcome Treatment
    1