BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 5366113 · Received January 14, 2016

    Report

    Report Number
    9611451-2016-00015
    Event Type
    Malfunction
    Date Received
    January 14, 2016
    Report Date
    December 15, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE RETURNED: DEVICE 1: MR290V; LOT 1505280304; DATE OF MANUFACTURE 28 MAY 2015; DEVICE 2: MR290V; LOT 1503090304; DATE OF MANUFACTURE 9 MARCH 2015; DEVICE 3: MR290V; LOT 1508100304; DATE OF MANUFACTURE 10 AUGUST 2015. METHOD: THREE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE THEY WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF THE RETURNED CHAMBERS REVEALED A CRACK IN THE CHAMBER DOME OF DEVICE 1. THE CRACK STARTS AT THE BASE AND STRETCHES UPWARDS. NO RESIDUE WAS FOUND AT THE CRACKS. NO REPORTABLE FAULTS WERE NOTED ON DEVICES 2 AND 3. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 150528. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE DAMAGE OBSERVED ON THE RETURNED MR290V CHAMBER. HOWEVER, BASED ON THE INSPECTION CARRIED OUT IT IS LIKELY THAT THE RETURNED CHAMBERS WERE EXPOSED TO PRESSURES GREATER THAN 8KPA. THE INTEGRITY OF THE CHAMBER CAN BE AFFECTED WHEN PRESSURE EXCEED 8 KPA. 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. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. ANY CHAMBER WHICH FAILS EITHER OF THESE TESTS IS REJECTED. THE RETURNED CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290 STATE THE FOLLOWING: MAXIMUM OPERATING PRESSURE: 8KPA; USE OF THE MR290 ABOVE THE MAXIMUM OPERATING PRESSURE MAY LEAD TO CRACKING, WATER LEAKAGE AND, ON RARE OCCASIONS, COULD LEAD TO A LOSS OF VENTILATION PRESSURE; PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT; DO NOT USE THE CHAMBER IF THE SEALS ARE NOT INTACT WHEN RECEIVED, OR IF IT HAS BEEN DROPPED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6), REPORTED THAT THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS CRACKED AND WAS LEAKING WATER FROM THE BASE. NO PATIENT CONSEQUNCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26783 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1505280304

    Patients

    Seq Age Sex Outcome Treatment
    1