BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 3915065 · Received July 6, 2014

    Report

    Report Number
    9611451-2014-00600
    Event Type
    Malfunction
    Date Received
    July 6, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 17, 2014
    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 AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED VERTICAL CRACKS ALL THE WAY ROUND THE BASE OF THE CHAMBER DOME. THE CRACKS DID NOT HAVE STRESS MARKS. THERE WERE NO SIGNS OF FLOW MARKS OR SMEARED PRINTING ON THE DOME. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT NUMBER 131114. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT HAD CAUSED THE CRACKING. THE MOST COMMON CAUSES OF CRACKING IN MR290 CHAMBERS ARE ENVIRONMENTAL STRESS CRACKING CAUSED BY THE USE OF HARSH CLEANING CHEMICALS, OR STRESSES INDUCED BY USE OF HIGH FREQUENCY VENTILATORS. 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 FACT THAT THE CHAMBER WAS USED FOR SIX DAYS BEFORE THE CRACKING OCCURRED SUGGESTS THAT THE CHAMBER WAS INITIALLY FUNCTIONING CORRECTLY. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER STATE THE FOLLOWING: DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS. MAXIMUM OPERATING PRESSURE: 8 KPA. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN MR290V HUMIDIFICATION CHAMBER WAS CRACKED AFTER SIX DAYS OF USE.NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393076 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1311140392

    Patients

    Seq Age Sex Outcome Treatment
    1 VERA VENTILATOR| FISHER & PAYKEL RT380 BREATHING CIRCUIT