BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2418847 · Received January 17, 2012

    Report

    Report Number
    9611451-2012-00021
    Event Type
    Malfunction
    Date Received
    January 17, 2012
    Date of Event
    November 17, 2011
    Report Date
    November 18, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: NINE COMPLAINT MR290V CHAMBERS WERE RECEIVED, WITH THE FOLLOWING LOT NUMBERS: LOT 090303: 1, LOT 090427: 1, LOT 090924:1, LOT 100914: 1, LOT 110114: 1, LOT 110719: 2, LOT 110805: 1, LOT 110806: 1. THE CHAMBERS WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED SCRATCHES OR STRESS MARKS ON THE DOMES OF ALL NINE CHAMBERS. IN ADDITION, THREE OF THE CHAMBERS HAD DENTS AND SCRATCHES ON THEIR BASES. CONCLUSION: THE NATURE OF THE CRACKING, AND THE FACT THAT IT WAS FOUND BEFORE USE OF THE CHAMBERS, SUGGESTS THAT THE DAMAGE OCCURED DURING TRANSPORTATION OR STORAGE OF THE CHAMBERS. EVERY MR290 CHAMBER IS PRESSURE TESTED TO 200CMH20 FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME 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. THIS SUGGESTS THAT THE CRACKS OCCURRED POST PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER STATE THE FOLLOWING: "SET APPROPRIATE VENTILATOR ALARMS." "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 WHEN UNPACKING SOME UNUSED MR290 AUTOFEED HUMIDIFICATION CHAMBERS THEY OBSERVED WHITE MARKS AND SCRATCHES ON THE CHAMBER DOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 090303

    Patients

    Seq Age Sex Outcome Treatment
    1