BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2981272 · Received February 27, 2013

    Report

    Report Number
    9611451-2013-00144
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    January 29, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT340 BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED COMPLAINT RT340 BREATHING CIRCUIT WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: VISUAL INSPECTION OF THE EVAQUA EXPIRATORY LIMB REVEALED A HOLE, ABOUT 86CM FROM THE PROXIMAL CONNECTOR. THE EVAQUA LIMB APPEARED TO HAVE BEEN PUNCTURED OR SCRATCHED WITH A BLUNT OBJECT. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR THE LOT NUMBER PROVIDED. CONCLUSION: WE WERE UNABLE TO DETERMINE HOW THE LIMB CAME TO BE DAMAGED. ALL RT340 BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO DISTRIBUTION AND THOSE THAT FAIL ARE REJECTED. (B)(4). THE USER INSTRUCTIONS SUPPLIED WITH THE RT340 BREATHING CIRCUIT STATE: PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT; SET APPROPRIATE VENTILATOR ALARMS; FIT ONLY THE SUPPLIED FISHER & PAYKEL HEALTHCARE CIRCUIT HANGER WITH CARE TO AVOID CIRCUIT DAMAGE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT340 ADULT BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST WHEN CHECKED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT340 ADULT BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST WHEN CHECKED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83719 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 120830

    Patients

    Seq Age Sex Outcome Treatment
    1