BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 8918574 · Received August 21, 2019

    Report

    Report Number
    9611451-2019-00807
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Report Date
    July 26, 2019
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTED DATA: SECTION IS AMENDED TO LOT NUMBER # 190315. METHOD: THE COMPLAINT MR290V HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) IN NEW ZEALAND FOR INVESTIGATION. VISUAL INSPECTION AND WATER LEVEL TESTING OF THE RETURNED MR290 CHAMBER WAS PERFORMED. RESULTS: VISUAL INSPECTION REVEALED NO DAMAGE TO THE CHAMBER. THE FLOATS WERE FOUND TO BE MOVING FREELY. DURING THE FUNCTIONAL TEST, THE WATER LEVEL OF BOTH PRIMARY AND SECONDARY FLOATS WAS CHECKED. BOTH FLOATS OPERATED CORRECTLY, AND THE WATER LEVEL ATTAINED WAS WITHIN SPECIFICATION. CONCLUSION: WE WERE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED ISSUE, AS THE COMPLAINT MR290 CHAMBER WAS FOUND TO BE OPERATING CORRECTLY. OVERFILLING OF WATER IS USUALLY CAUSED BY BOTH THE PRIMARY AND SECONDARY FLOAT MECHANISMS IN THE MR290 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: "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 · 0

    A HOSPITAL IN BRAZIL REPORTED TO A FISHER AND PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT THE MR290V HUMIDIFICATION CHAMBER OVERFILLED. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290 HUMIDIFICATION CHAMBER IS CURRENTLY EN-ROUTE TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER AND PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT THE MR290V HUMIDIFICATION CHAMBER OVERFILLED. THERE IS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712823 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 190315

    Patients

    Seq Age Sex Outcome Treatment
    1