BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 5062505 · Received September 8, 2015

    Report

    Report Number
    9611451-2015-00397
    Event Type
    Malfunction
    Date Received
    September 8, 2015
    Date of Event
    August 14, 2015
    Report Date
    August 14, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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). LOT # AND DEVICE MANUFACTURE DATE: LOT NUMBER: 150311, 150609; MANUFACTURING DATE: 03/11/2015, 06/09/2015; QUANTITY AFFECTED: 2, 2. METHOD: THE FOUR COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FPH IN (B)(4) AND WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT ALL RETURNED CHAMBERS SUSTAINED CRACKS ALONG THE BASE OF THE CHAMBER DOME. RESIDUE WAS ALSO FOUND ON ALL CHAMBER DOMES. SMEARED PRINTS WERE ALSO OBSERVED ON THE DOMES OF THE CHAMBERS WITH LOT NUMBER 150609. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBERS 150311 AND 150609. CONCLUSION:THE NATURE OF THE CRACKING, RESIDUE AND SMEARED PRINTS SUGGEST THAT THE DAMAGE WAS CAUSED BY THE CHAMBERS COMING INTO CONTACT WITH A SOLUTION CONTAINING ETHANOL/ALCOHOL, WHICH HAS RESULTED IN ENVIRONMENTAL STRESS CRACKING OF THE CHAMBER DOMES. EVERY MR290 CHAMBER IS PRESSURE TESTED TO 200 CMH2O 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." - "MAXIMUM OPERATING PRESSURE: 8 KPA." OUR MONITORING AND TRENDING OF COMPLAINTS INVOLVING ENVIRONMENTAL STRESS CRACKING IN MR290 CHAMBERS HAS A RATE OF OCCURRENCE OF 9 DEVICES PER MILLION SOLD WORLDWIDE IN THE LAST YEAR TO THE END OF AUGUST 2015.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT FOUR MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE FOUND CRACKED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591908 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1