BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 7628059 · Received June 21, 2018

    Report

    Report Number
    9611451-2018-00524
    Event Type
    Malfunction
    Date Received
    June 21, 2018
    Date of Event
    May 18, 2018
    Report Date
    May 24, 2018
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE 1: LOT 170711, DATE OF MANUFACTURE: 11 JULY 2017. DEVICE 2: LOT171020, DATE OF MANUFACTURE: 20 OCTOBER 2017. METHOD: TWO COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INVESTIGATION. THE CHAMBERS WERE VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED A HORIZONTAL CRACK AROUND THE BASE OF THE CHAMBER DOME OF DEVICE 1, BELOW ONE OF THE PORTS. A SMEARED PRINT WAS FOUND ABOVE THE CRACK OF DEVICE 1. TWO CRACKS WERE OBSERVED ON THE CHAMBER DOME OF DEVICE 2; ONE BELOW ONE OF THE PORTS AND THE OTHER AT THE BRACKET. A SMEARED PRINT AND RESIDUE WAS FOUND ON THE CHAMBER DOME OF DEVICE 2. CONCLUSION: THE NATURE OF THE CRACKING AND THE SMEARED PRINT SUGGEST THAT THE DAMAGE WAS CAUSED BY THE CHAMBER COMING INTO CONTACT WITH A SOLUTION CONTAINING ETHANOL/ALCOHOL, WHICH HAS RESULTED IN ENVIRONMENTAL STRESS CRACKING OF THE CHAMBER DOME. 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. 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. MOREOVER, THE HOSPITAL REPORTED THAT THE LEAK 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 MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER STATE THE FOLLOWING: - "DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS." - "SET APPROPRIATE VENTILATOR ALARMS." - "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 FISHER & PAYKEL HEALTHCARE REPRESENTATIVE, THAT A MR290V HUMIDIFICATION CHAMBER WAS LEAKING DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468047 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 170711

    Patients

    Seq Age Sex Outcome Treatment
    1