BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 5680381 · Received May 25, 2016

    Report

    Report Number
    9611451-2016-00231
    Event Type
    Malfunction
    Date Received
    May 25, 2016
    Report Date
    April 25, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) RETURNED DEVICES: MR290V; LOT: 1501140304; DATE OF MANUFACTURE: 14 JANUARY 2015. MR290V; LOT: 150519; DATE OF MANUFACTURE: 19 MAY 2015. MR290V; LOT: 150825; DATE OF MANUFACTURE: 25 AUGUST 2015. METHOD: THREE MR290V VENTED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4). THEY WERE VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED HORIZONTAL CRACKS ON THE CHAMBER DOMES ON ALL THREE MR290V CHAMBERS. RESIDUE WAS FOUND AROUND THE CRACK ON ONE OF THE CHAMBERS WHILE SMEARED PRINT WAS OBSERVED ON ALL THREE CHAMBERS. CONCLUSION: THE RESIDUE AND SMEARED PRINT ON THE DEVICES INDICATE THAT THE CHAMBERS WERE IN CONTACT WITH A SOLUTION CONTAINING ALCOHOL WHICH RESULTED IN STRESS CRACKING OF THE CHAMBER DOME. ALL MR290 CHAMBERS ARE VISUALLY INSPECTED AND PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE. CHAMBERS THAT FAIL ANY OF THESE TESTS ARE DISCARDED. THIS SUGGESTS THAT THE PROBLEM OCCURRED AFTER THE SUBJECT MR290 CHAMBERS WERE 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. 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 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 THAT THREE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE CRACKED AND LEAKING DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334983 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 150114, 150519 & 150825

    Patients

    Seq Age Sex Outcome Treatment
    1