BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 5764188 · Received June 30, 2016

    Report

    Report Number
    9611451-2016-00292
    Event Type
    Malfunction
    Date Received
    June 30, 2016
    Date of Event
    June 2, 2016
    Report Date
    June 3, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    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 MR290 HUMIFICATION CHAMBER WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE IT WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED MULTIPLE VERTICAL CRACKS IN THE CHAMBER DOME UNDERNEATH ONE OF THE PORTS. THE SUBJECT CHAMBER SHOWED SIGNS OF USE WITH RESIDUE PRESENT INSIDE AND OUTSIDE THE CHAMBER. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS OF THIS NATURE FOR LOT 151209. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT HAD CAUSED THE CRACKS OBSERVED ON THE CHAMBER DOME. HOWEVER, IT IS KNOWN THAT PRESSURE IN EXCESS OF 80CMH20 MAY AFFECT THE INTEGRITY OF THE CHAMBER AND RESULT IN THIS TYPE OF CRACKING. THE CRACKS ON THE CHAMBER DOME ARE MOST LIKELY THE CAUSE OF THE LEAK THAT THE HOSPITAL REPORTED. EVERY MR290 CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER 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 SUBJECT MR290V CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THE CRACK ON THE CHAMBER DOME OCCURRED AFTER TWO OR THREE DAYS OF USE SUGGESTS THAT IT WAS INITIALLY FUNCTIONING CORRECTLY. THE USER INSTRUCTIONS THAT ACCOMPANY THE MR290V VENTED AUTOFEED HUMIFICATION CHAMBER STATE THE FOLLOWING: "DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS." "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." "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 HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN MR290 HUMIDIFICATION CHAMBER DOME WAS LEAKING. THE HOSPITAL REPORTED THAT THE EVENT WAS DISCOVERED BEFORE PATIENT USE DURING SETUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418212 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 2100010885

    Patients

    Seq Age Sex Outcome Treatment
    1