BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2962840 · Received February 14, 2013

    Report

    Report Number
    9611451-2013-00099
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Report Date
    January 16, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290 AUTOFEED HUMIDIFICATION CHAMBERS WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WITHOUT THE RETURN OF THE COMPLAINT DEVICES WE ARE UNABLE TO DETERMINE THE CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER. ALL MR290 AUTOFEED HUMIDIFICATION CHAMBERS ARE 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. THE USER INSTRUCTIONS THAT ACCOMPANY THE MR290 CHAMBER SPECIFY TO THE USER TO "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM BEFORE CONNECTING TO A PATIENT", TO REFRAIN FROM USING THE CHAMBER IF IT HAS BEEN DROPPED AND "TO SET THE APPROPRIATE VENTILATOR ALARMS" IN THE EVENT A LEAK OCCURS. IT ALSO STATES THAT THE MAXIMUM OPERATING PRESSURE IS 8KPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(4) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT TWO MR290 AUTOFEED HUMIDIFICATION CHAMBERS WERE LEAKING WATER WHEN USED WITH A NASAL CPAP SYSTEM. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT TWO MR290 AUTOFEED HUMIDIFICATION CHAMBERS WERE LEAKING WATER WHEN USED WITH A NASAL CPAP SYSTEM. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64461 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 120614

    Patients

    Seq Age Sex Outcome Treatment
    1