BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 6038963 · Received October 19, 2016

    Report

    Report Number
    9611451-2016-00671
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    July 21, 2016
    Report Date
    September 20, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FPH IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED MULTIPLE VERTICAL CRACKS ON THE CHAMBER DOME. THE CRACKS WERE FOUND AT THE BRACKET, BAFFLE AND ONE OF THE PORTS. RESIDUE AND STRESS MARK WERE ALSO OBSERVED ON THE CHAMBER DOME, NEAR THE BASE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 160309. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT HAD CAUSED THE CRACKING ON THE CHAMBER DOME; HOWEVER, OUR PREVIOUS INVESTIGATIONS ON SIMILAR COMPLAINTS SHOWED THAT CRACK ON THE CHAMBER DOME CAN BE DUE TO THE APPLICATION OF EXCESSIVE PRESSURE. THE INTEGRITY OF THE CHAMBER CAN BE AFFECTED WHEN PRESSURE EXCEEDS 80CMH2O. 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 CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. MOREOVER, THE HOSPITAL REPORTED THAT THE DAMAGE OCCURRED AFTER A PERIOD OF USE, WHICH SUGGESTS THAT THE SUBJECT MR290 CHAMBER BECAME DAMAGED AFTER IT WAS RELEASED FOR DISTRIBUTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290 STATE THE FOLLOWING: "USE OF THE MR290 ABOVE THE MAXIMUM OPERATING PRESSURE [8KPA (~80CMH2O)] 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." "SET APPROPRIATE VENTILATOR ALARM."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE DOME OF AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS FOUND CRACKED AFTER 28 DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693619 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 160309

    Patients

    Seq Age Sex Outcome Treatment
    1