BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2348616 · Received November 25, 2011

    Report

    Report Number
    9611451-2011-00733
    Event Type
    Malfunction
    Date Received
    November 25, 2011
    Date of Event
    October 28, 2011
    Report Date
    October 28, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBERS: 110331 X1, 110501 X1, 110601 X2, 110714 X1. MANUFACTURING DATES: 03/31/2011, 05/01/2011, 06/01/2011, 07/14/2011. METHOD: THE COMPLAINT MR290 CHAMBERS WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AS THEY WERE NOT AVAILABLE. OUR INVESTIGATION IS BASED ON SKETCHES SHOWING THE LOCATION OF THE DAMAGE PROVIDED BY OUR SALES REPRESENTATIVE. RESULTS: THE PROVIDED SKETCHES REVEALED THAT THE CHAMBER DOMES WERE CRACKED ALONG THE BASE, BELOW ONE OF THE CHAMBER PORTS. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS TYPE FOR LOT 110331, AND NO OTHER COMPLAINTS OF THIS TYPE FOR LOTS 110501, 110601, 110714. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM OBSERVED BY THE CUSTOMER. AN IN-DEPTH INVESTIGATION FOR CHAMBER DOME CRACKS IS CURRENTLY IN PROGRESS BUT NOT RESULTS ARE AVAILABLE YET. 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, POSSIBLY DURING TRANSPORT OR STORAGE. FISHER & PAYKEL HEALTHCARE'S USER INSTRUCTIONS THAT ACCOMPANY THE MR290 CHAMBER SPECIFY TO THE USER TO "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM BEFORE CONNECTING TO A PATIENT", TO REFRAIN FROM USING THE CHAMBER IF IT HAS BEEN DROPPED AND "TO SET THE APPROPRIATE VENTILATOR ALARMS" IN THE EVENT A LEAK OCCURS.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE BAFFLE OF FIVE MR290 AUTOFEED HUMIDIFICATION CHAMBERS WERE DAMAGED AFTER 1 TO 5 DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 LEONI VENTILATOR