BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MANUAL FEED ADULT HUMIDIFICATION CHAMBER

    MDR report key: 3072066 · Received April 22, 2013

    Report

    Report Number
    9611451-2013-00315
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 25, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K913368
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR250 CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4). THE COMPLAINT DEVICE WAS VISUALLY INSPECTED AND PRESSURE TESTED TO CHECK FOR LEAKS. RESULTS: VISUAL INSPECTION REVEALED NO DAMAGE FOUND ON THE COMPLAINT DEVICE. THE PRESSURE TEST REVEALED THAT THE COMPLAINT DEVICE PERFORMED WITHIN SPECIFICATION. A LOT CHECK REVEALED ONE OTHER COMPLAINTS OF THIS TYPE FOR LOT NUMBER 071207. CONCLUSION: WE WERE UNABLE TO CONFIRM THE REPORTED EVENT AS NO FAULT WAS FOUND WITH THE COMPLAINT DEVICE. EVERY MR250 CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. ANY CHAMBER WHICH FAILS EITHER OF THESE TESTS IS REJECTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT A WATER LEAK OCCURRED AT THE CONNECTION BETWEEN THE MR250 HUMIDIFICATION CHAMBER DOME AND BASE PLATE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171824 MANUAL FEED ADULT HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR250 111126

    Patients

    Seq Age Sex Outcome Treatment
    1