BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIGH FREQUENCY VENTED HUMIDIFICATION CHAMBER

    MDR report key: 1051757 · Received May 19, 2008

    Report

    Report Number
    9611451-2008-00264
    Event Type
    Malfunction
    Date Received
    May 19, 2008
    Report Date
    April 17, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS VISUALLY INSPECTED. RESULTS: THE CHAMBER DOME WAS OBSERVED TO BE OFF CENTRE ON THE CHAMBER BASE AND AT ONE POINT THERE WAS AN INCOMPLETE SEAL BETWEEN THE GASKET AND THE CHAMBER DOME. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR THIS LOT NUMBER. CONCLUSION: THIS FAULT IS DUE TO IMPROPER ASSEMBLY OF THE CHAMBER ON THE PRODUCTION LINE. IT IS LIKELY THE DOME HAS BEEN PLACED OFF CENTER DURING MANUFACTURE, AND THIS HAS PREVENTED THE FORMATION OF A SECURE SEAL BETWEEN THE GASKET AND THE LIP OF THE CHAMBER DOME. THIS FAULT WAS NOT PICKED UP AT VISUAL INSPECTION DURING PRODUCTION. ALL CHAMBERS ARE PRESSURE TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE CHAMBER FORMED A WEAK SEAL DURING PRODUCTION THAT SUBSEQUENTLY FAILED DURING USE WHEN THE ALUMINUM BASE WAS HEATED, RESULTING IN A LEAK. OUR MONITORING AND TRENDING FOR THIS TYPE OF EVENT SHOWS A RATE OF OCCURRENCE WORLDWIDE FOR THE PAST 11 MONTHS OF 0.0007%.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED THAT AN MR290HFV HIGH FREQUENCY VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS LEAKING AT THE BASE SEAL. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIGH FREQUENCY VENTED HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR290HFV 071208

    Patients

    Seq Age Sex Outcome Treatment
    1