BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1672861 · Received April 29, 2010

    Report

    Report Number
    9611451-2010-00246
    Event Type
    Malfunction
    Date Received
    April 29, 2010
    Date of Event
    March 24, 2010
    Report Date
    March 30, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT# 090919, DATE OF MANUFACTURE: 09/19/2009. METHOD: THE TWO (2) COMPLAINT HUMIDIFICATION CHAMBERS WERE VISUALLY INSPECTED AND TESTED WITH VENT FILTER SPIKES. RESULTS: THE VENT SPIKE FILTER HAD BEEN REMOVED FROM THE VENT SPIKE BODY OF THE FIRST COMPLAINT CHAMBER. THE FILTER WAS REINSERTED INTO THE SPIKE AND TESTED. THE FILTER CAP OPENED WITHOUT THE FILTER BEING REMOVED. THE VENT SPIKE FILTER WAS MISSING FROM THE VENT SPIKE BODY OF THE SECOND COMPLAINT CHAMBER. A VENT SPIKE FILTER WAS INSERTED INTO THE SPIKE BODY AND TESTED. THE FILTER CAP OPENED WITHOUT THE FILTER BEING REMOVED. CONCLUSION: ALL MR290 AUTOFEED HUMIDIFICATION CHAMBERS ARE PRESSURE TESTED FOLLOWING THE MFG PROCESS TO CHECK FOR LEAKS. ANY CHAMBER WHICH FAILS THE PRESSURE TEST IS REJECTED. A LOOSE OR MISSING VENT SPIKE FILTER WOULD CAUSE THE CHAMBER TO FAIL THE LEAK TEST. THIS SUGGESTS THAT THE FILTERS WERE REMOVED POST-PRODUCTION, POSSIBLY DURING SET-UP. IT IS POSSIBLE THAT EXCESSIVE FORCE WAS APPLIED TO TRY AND REMOVE THE CAPS INCORRECTLY, CAUSING THE FILTERS TO DETACH. THE FORCE REQUIRED TO OPEN THE CAP IS LESS THAN THE FORCE REQUIRED TO REMOVE THE FILTER. WHEN THE CHAMBER FILTERS WERE TESTED, THERE WAS NO FAULT FOUND AS THE CAPS OPENED WITHOUT THE FILTERS BEING REMOVED. (B)(4).

    Description of Event or Problem · 1

    A HOSP IN (B)(6) REPORTED VIA A DISTRIBUTOR, THAT THE TWO (2) MR290 AUTOFEED HUMIDIFICATION CHAMBER HAD DYSFUNCTIONAL VENTED HOLES. IT WAS REPORTED THAT THE FAULTS WERE FOUND PRIOR TO PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR290V 090505

    Patients

    Seq Age Sex Outcome Treatment
    1