BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 6077959 · Received November 3, 2016

    Report

    Report Number
    9611451-2016-00739
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    October 1, 2016
    Report Date
    October 5, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE 1: LOT 160409, DATE OF MANUFACTURE APRIL 9, 2016. DEVICE 2: LOT 140327, DATE OF MANUFACTURE MARCH 27, 2014. THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INVESTIGATION AS THEY WERE DESTROYED BY THE HEALTHCARE FACILITY. THEREFORE, OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, PREVIOUS SIMILAR INVESTIGATIONS AND OUR KNOWLEDGE OF THE PRODUCT. WITHOUT THE COMPLAINT DEVICE, WE WERE UNABLE TO DEFINITIVELY DETERMINE THE ROOT CAUSE OF THE FAULT REPORTED BY THE HOSPITAL. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THE LOT NUMBERS PROVIDED. OVERFILLING OF WATER IS USUALLY CAUSED BY BOTH THE PRIMARY AND SECONDARY FLOAT MECHANISMS IN THE MR290 HUMIDIFICATION CHAMBER BEING DISABLED. IN CIRCUMSTANCES WHERE THE PRIMARY FLOAT IS DISABLED, THE WATER MAY OVERFILL ABOVE THE BLACK WATER LEVEL LINE OF THE CHAMBER BUT THE SECONDARY FLOAT WILL SERVE AS A BACKUP TO PREVENT THE WATER FROM OVERFLOWING OUTSIDE THE CHAMBER PORT AND ENTERING INTO THE BREATHING CIRCUIT. ALL MR290 CHAMBERS HAVE FLOAT FUNCTION AND VALVE TESTING PERFORMED TWICE DURING PRODUCTION. A FAILURE OF ANY TEST WOULD RESULT IN REJECTION OF THE CHAMBER BEFORE DISTRIBUTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE MR290 HUMIDIFICATION CHAMBER SPECIFY IN THE WARNING SECTION "DO NOT USE THE CHAMBER IF THE WATER RISES ABOVE THE MAXIMUM WATER LEVEL LINE" ALONG WITH A DIAGRAM DIRECTING THE USER TO CHECK THE WATER LEVEL ON THE CHAMBER. A WRITTEN DESCRIPTION OF THE MEANING OF THE SYMBOLS USED IS ALSO INCLUDED IN THE USER INSTRUCTIONS. IT ALSO STATES THE FOLLOWING: "DO NOT SPIKE THE WATER SOURCE UNTIL THE BLUE CAPS HAVE BEEN REMOVED. SHOULD THE PRIMARY FLOAT FAIL, SPLASHING INTO THE CIRCUIT MAY OCCUR IF THE CHAMBER IS BEING OPERATED IN EXCESS OF 80L/MIN." "SET APPROPRIATE VENTILATOR ALARM." "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 HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT TWO MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBERS SPILLED OVER THE WATER LEVEL LINE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727102 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 160409, 140327

    Patients

    Seq Age Sex Outcome Treatment
    1 BABYLOG VENTILATOR| PB840 VENTILATOR