BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BI-LEVEL/CPAP INSPIRATORY-HEATED BREATHING CIRCUIT

    MDR report key: 2676710 · Received July 31, 2012

    Report

    Report Number
    9611451-2012-00516
    Event Type
    Malfunction
    Date Received
    July 31, 2012
    Date of Event
    July 4, 2012
    Report Date
    July 5, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT319 ADULT BI-LEVEL/CPAP INSPIRATORY-HEATED BREATHING CIRCUIT THAT IS REFERRED TO IN THE EVENT DESCRIPTION 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 COMPLAINT RT319 ADULT BREATHING CIRCUIT WAS RETURNED TO FPH IN (B)(4) FOR INSPECTION. IT WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A CUT ABOUT 20CM LONG AT THE SIDE OF THE INSPIRATORY LIMB. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 111221. CONCLUSION: BASED ON INSPECTION OF THE DAMAGE, IT IS LIKELY THAT THE INSPIRATORY LIMB WAS CUT WITH A SHARP OBJECT. ALL ADULT BREATHING CIRCUITS ARE VISUALLY INSPECTED FOR ANY CUTS OR HOLES BEFORE LEAVING THE PRODUCTION LINE, AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT RT319 ADULT BREATHING CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THIS SUGGESTS THAT THE AFFECTED BREATHING CIRCUIT WAS DAMAGED POST PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT319 ADULT BI-LEVEL/CPAP INSPIRATORY-HEATED BREATHING CIRCUIT STATE THE FOLLOWING: "BEFORE CONNECTING TO A PATIENT, ENSURE THAT FLOW AND PRESSURE TESTING APPLICABLE TO THE VENTILATOR HAS BEEN COMPLETED." "SET APPROPRIATE VENTILATOR ALARMS." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN RT319 ADULT BI-LEVEL/CPAP INSPIRATORY-HEATED BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST. IT WAS FURTHER REPORTED THAT "A LOT OF AIR BUBBLES" WERE OBSERVED ON THE SURFACE OF THE BREATHING CIRCUIT DURING LEAK TEST. THIS WAS NOTICED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BI-LEVEL/CPAP INSPIRATORY-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT319 111221

    Patients

    Seq Age Sex Outcome Treatment
    1