BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1912142 · Received December 1, 2010

    Report

    Report Number
    9611451-2010-00725
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 29, 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

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY ENDEAVOURING TO OBTAIN MORE INFORMATION FROM THE CUSTOMER WITH REGARD TO THE COMPLAINT DEVICE. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED COMPLAINT CHAMBER WAS VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION REVEALED A CRACK FROM THE CLEFT OF THE FRONT BAFFLE AND EXTENDING ALMOST TO THE BASE OF THE CHAMBER DOME. A LOT CHECK REVEALED NO COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: EVERY MR290 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. THIS SUGGESTS THAT THE CHAMBER WAS DAMAGED POST PRODUCTION, POSSIBLY DURING TRANSPORT OR STORAGE AT THE CUSTOMER FACILITY. 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 LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT". (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBER BEGAN LEAKING "IMMEDIATELY" AFTER USE. THE HOSPITAL FURTHER REPORTED THAT THERE WAS A CRACK ON THE SIDE OF THE CHAMBER. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBER BEGAN LEAKING "IMMEDIATELY" AFTER USE. THE HOSPITAL FURTHER REPORTED THAT THERE WAS A CRACK ON THE SIDE OF THE CHAMBER. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 100501

    Patients

    Seq Age Sex Outcome Treatment
    1