BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEATED OXYGEN THERAPY KIT

    MDR report key: 2063660 · Received April 20, 2011

    Report

    Report Number
    9611451-2011-00260
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 24, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EN ROUTE TO THE MANUFACTURER. WE WILL PROVIDE A FINAL REPORT FOLLOWING RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED INSPIRATORY LIMB WAS VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: A HOLE WITH ROUGH EDGES WAS FOUND IN THE MIDDLE OF THE INSPIRATORY LIMB. THE PRESSURE TEST REVEALED THAT THE CIRCUIT WAS OUT OF SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR THIS LOT NUMBER. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT CAUSED THE OBSERVED DAMAGE TO THE CIRCUIT, BUT IT MOST LIKELY HAPPENED DURING TRANSPORT OR WHILE IN STORAGE OR USE AT THE CUSTOMER FACILITY. ALL CIRCUITS ARE PRESSURE AND FLOW TESTED BEFORE THEY ARE ALLOWED TO LEAVE THE PRODUCTION LINE. THIS IS AN AUTOMATED PROCESS AND THE CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE INSPIRATORY LIMB OF AN RT308 HEATED OXYGEN THERAPY KIT HAD A HOLE IN IT. THIS WAS FOUND BEFORE PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED THAT THE INSPIRATORY LIMB OF AN RT308 HEATED OXYGEN THERAPY KIT HAD A HOLE IN IT. THIS WAS FOUND BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEATED OXYGEN THERAPY KIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT308 100729

    Patients

    Seq Age Sex Outcome Treatment
    1