BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1764595 · Received July 14, 2010

    Report

    Report Number
    9611451-2010-00438
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Date of Event
    June 18, 2010
    Report Date
    June 25, 2010
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED MR290 CHAMBER WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: THE CHAMBER DOME WAS CRACKED. THERE ARE DIRTY MARKS AT THE ORIGIN OF THE CRACK. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100327. CONCLUSION: ALL MR290 AUTOFEED HUMIDIFICATION CHAMBERS ARE PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS OR OTHER CAUSES. FOLLOWING PRESSURE TESTING, EACH CHAMBER IS VISUALLY INSPECTED. ANY CHAMBER WHICH FAILS EITHER OF THESE TESTS IS REJECTED. THIS SUGGESTS THAT THE CHAMBER WAS DAMAGED POST-PRODUCTION. THE DAMAGE IS CONSISTENT WITH DAMAGE CAUSE BY PHYSICAL IMPACT TO THE CHAMBER DOME. THE DEVICE USER INSTRUCTIONS STATE THE FOLLOWING: "DO NOT USE THE CHAMBER IF THE SEALS ARE NOT INTACT WHEN RECEIVED, OR IF IT HAS BEEN DROPPED". "PERFORM A PRESSURE AND LEAD TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT". THE CHAMBER CRACK WAS OBSERVED BY HOSPITAL PRIOR TO PATIENT USE. ACCORDINGLY, THERE WAS NO PATIENT CONSEQUENCE. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN MR290 AUTOFEED HUMIDIFICATION CHAMBER HAD A CRACKED DOME. THE CRACK WAS FOUND BY THE HOSPITAL PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 100327

    Patients

    Seq Age Sex Outcome Treatment
    1