BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 1755733 · Received July 14, 2010

    Report

    Report Number
    9611451-2010-00444
    Event Type
    Malfunction
    Date Received
    July 14, 2010
    Report Date
    June 16, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE RT200 IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. METHOD: THE THREE COMPLAINT RT200 ADULT DUAL HEATED BREATHING CIRCUITS WERE VISUALLY INSPECTED FOR CUTS. RESULTS: EACH OF THE THREE COMPLAINT BREATHING CIRCUITS WERE FOUND TO HAVE CUTS ON THE DRY LINE OF THE BREATHING CIRCUIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100217. CONCLUSION: A LEAK IN THE BREATHING CIRCUIT IS USUALLY DETECTED BY AN ALARM ON THE VENTILATOR. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT IT WAS PUNCTURED POST PRODUCTION. THIS TYPE OF CUT ON THE DRY LINE DURING PRODUCTION IS POSSIBLE IF THERE WAS A PROBLEM WITH THE FORMING BLOCK ON THE EXTRUDER MACHINE. THE USER INSTRUCTIONS THAT ACCOMPANY THE DEVICE STATE: CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE, SET APPROPRIATE VENTILATOR ALARMS. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THREE RT200 ADULT BREATHING CIRCUITS FAILED THE LEAK TEST ON A PB840 VENTILATOR. THIS WAS FOUND BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT200 100217

    Patients

    Seq Age Sex Outcome Treatment
    1