BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 4519848 · Received February 16, 2015

    Report

    Report Number
    9611451-2015-00088
    Event Type
    Malfunction
    Date Received
    February 16, 2015
    Date of Event
    January 19, 2015
    Report Date
    January 26, 2015
    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 CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WERE VISUALLY INSPECTED AND PRESSURE TESTED FOR THE REPORTED LEAK. RESULTS: VISUAL INSPECTION OF THE RETURNED CHAMBERS REVEALED THAT ONE CHAMBER WAS CRACKED ON THE CHAMBER DOME, BETWEEN THE BAFFLE AND PORT. WHITE STRESS MARKS WERE PRESENT ABOVE THE CRACK AND THE ALUMINIUM BASE BELOW THE CRACK WAS SLIGHTLY DENTED. THE OTHER CHAMBER SHOWED NO DAMAGE. PRESSURE TESTING OF BOTH CHAMBERS IDENTIFIED NO LEAK AND THE RETURNED CHAMBERS OPERATED WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT NUMBER 140515. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT HAD CAUSED THE CRACKING OF THE CHAMBER. HOWEVER, THE STRESS MARK AND DENT IN THE BASE INDICATES THAT THE CRACK IS MOST LIKELY DUE TO IMPACT DAMAGE. THE REPORTED LEAKING OF THE CHAMBERS COULD NOT BE REPLICATED. THE CUSTOMER CONFIRMED THAT THE CHAMBER FEEDSET SPIKE WAS LEFT IN THE BAG SPIKE SHEATH DURING THE LEAK TEST. THE BAG SHEATH IS FOR THE PREVENTION OF CONTAMINATION AND DAMAGE TO THE BAG SPIKE DURING TRANSPORT ONLY. THIS SUGGESTS THAT THE RETURNED CHAMBERS FAILED THE VENTILATOR LEAK TEST DUE TO A SET-UP ISSUE. 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. NO CRACKS IN THE CHAMBER DOME ARE ACCEPTABLE. ANY CHAMBERS WHICH FAIL THIS INSPECTION ARE REJECTED. 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 THE HOSPITAL STAFF CORRECTLY CHECKED THE BREATHING CIRCUIT BEFORE PATIENT USE, WHICH IS IN LINE WITH OUR USER INSTRUCTIONS. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT TWO MR290V HUMIDIFICATION CHAMBERS FAILED THE SERVO-I VENTILATOR LEAK TEST. THIS WAS FOUND BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112167 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1405150306

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL RT105 BREATHING CIRCUIT| SERVO-I VENTILATOR