BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2011085 · Received March 8, 2011

    Report

    Report Number
    9611451-2011-00138
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    December 7, 2010
    Report Date
    February 7, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBERS: 100808, 091203, 100402, UNKNOWN. DEVICE MANUFACTURER DATE: 08/08/2010, 12/03/2009, 04/02/2010. METHOD: THE SIX RETURNED COMPLAINT CHAMBERS WERE VISUALLY INSPECTED AND PRESSURE TESTED. ONE COMPLAINT CHAMBER HAD LOT NUMBER 091203, ONE COMPLAINT CHAMBER HAD LOT NUMBER 100402, FOUR COMPLAINT CHAMBERS HAD LOT NUMBER 100808. RESULTS: THE VISUAL INSPECTION REVEALED THAT ALL SIX CHAMBERS WERE DEFORMED NEAR THE CHAMBER BASE. ON ALL SIX COMPLAINT CHAMBERS THERE WERE WHITE MARKS OBSERVED NEAR THE CHAMBER BASE, UP TO THE MAXIMUM WATER FILL LINE. ALL SIX COMPLAINT CHAMBERS WERE PRESSURE TESTED. THE PRESSURE TEST REVEALED THE PRESSURE DROP FOR ALL SIX CHAMBERS TO BE OUTSIDE SPECIFICATION. A LOT CHECK REVEALED: THERE HAS BEEN NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 091203. (B)(4) OTHER SIMILAR COMPLAINT OF THIS NATURE FOR LOT 100402. THERE HAS BEEN NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 100808. CONCLUSION: WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE PROBLEM OBSERVED BY THE CUSTOMER. A FISHER AND PAYKEL HEALTHCARE REPRESENTATIVE IS SCHEDULING A TIME TO VISIT THE HEALTHCARE FACILITY. SHOULD ANY NEW INFORMATION ARISE, WE WILL PROVIDE A FOLLOW-UP REPORT. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER STATE "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT".

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICES HAVE BEEN RETURNED TO THE MANUFACTURER FISHER & PAYKEL HEALTHCARE, (B)(4). WE ARE CURRENTLY ENDEAVOURING TO OBTAIN FURTHER INFORMATION WITH REGARD TO THE COMPLAINT AND WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE WAS LEAKAGE FROM THE BASE OF THE MR290VX VENTED AUTOFEED CHAMBERS. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE WAS LEAKAGE FROM THE BASE OF THE (B)(4) VENTED AUTOFEED CHAMBERS. NO PATIENT CONSEQENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290VX SEE. H.10

    Patients

    Seq Age Sex Outcome Treatment
    1