BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1035300 · Received April 24, 2008

    Report

    Report Number
    9611451-2008-00213
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    February 25, 2008
    Report Date
    March 12, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT # AFFECTED WERE: 080122. THE MFR DATES WERE: 01/22/2008. THE DEVICE WERE NOT RETURNED TO THE MFR. AN INVESTIGATION WAS CARRIED OUT BASED ON A PHOTOGRAPH OF THE DEVICE SENT BY THE DISTRIBUTOR. RESULTS: THE PORT CAPS OF THE CHAMBER HAVE 2 LEGS THAT HOLD THE PRIMARY FLOAT OF THE CHAMBER IN PLACE DURING TRANSPORTATION. THE PORT CAPS ARE REMOVED DURING SETUP FOR USE. IN THE PHOTOGRAPH A PORT CAP LEG APPEARED TOO SHORT AND DID NOT REACH THE CHAMBER BASE. CONCLUSION: THE LEGS OF THE PORT CAPS HOLD THE PRIMARY AND SECONDARY FLOATS TO THE CHAMBER BASE, SECURING THEM DURING TRANSPORT AND ARE REMOVED ON SETUP. IT IS LIKELY THAT INCOMPLETE INSERTION OF THE PORT CAPS CAUSED THE SECONDARY FLOAT LEGS NOT TO BE PUSHED COMPLETELY TO THE HUMIDIFIER BASE. SINCE THE LEG DID NOT REACH DOWN AS FAR, IT MAY HAVE ALLOWED THE FLOATS TO MOVE DURING TRANSPORT. PORT CAPS ARE INSERTED ON TWO DIFFERENT PRODUCTION LINES EITHER PARTLY OR COMPLETELY BY HAND. IT IS LIKELY THAT THIS EVENT WAS A RESULT OF OPERATOR ERROR. THERE WAS ONE OTHER SIMILAR COMPLAINT REPORTED FOR THE TWO LOT NUMBERS INVOLVED. OUR MONITORING AND TRENDING FOR THIS TYPE OF EVENT HAS A RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YR OF 0.0001%.

    Description of Event or Problem · 1

    OUR DISTRIBUTOR REPORTED THAT ON A QUANTITY OF 12 MR290 AUTOFEED HUMIDIFICATION CHAMBERS, THE PORT CAP LEG WAS TOO SHORT. THIS WAS DETECTED DURING AN INWARD GOODS QUALITY INSPECTION. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR290 080125

    Patients

    Seq Age Sex Outcome Treatment
    1