BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2751647 · Received September 19, 2012

    Report

    Report Number
    9611451-2012-00646
    Event Type
    Malfunction
    Date Received
    September 19, 2012
    Date of Event
    August 7, 2012
    Report Date
    August 21, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. THE DRYLINE WAS VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: THE VISUAL INSPECTION IDENTIFIED A HOLE APPROXIMATELY 10CM FROM THE CONNECTOR ON THE RETURNED DRYLINE TUBE. A LOT CHECK REVEALED SEVEN OTHER SIMILAR COMPLAINTS FOR THE LOT NUMBER 120127. CONCLUSION: IT WAS IDENTIFIED THAT THE DAMAGE TO THE RT340 DRYLINE COULD HAVE BEEN CAUSED DURING THE MANUFACTURING PROCESS. DURING THE PRODUCTION OF THE DRYLINE TUBES, A PRESSURE TEST IS PERFORMED EVERY 10 TO 15 MINUTES AND THOSE THAT FAIL ARE SET ASIDE FOR FURTHER INSPECTION. THE USER INSTRUCTIONS SUPPLIED WITH THE RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT STATE THE FOLLOWING: -PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT; -SET APPROPRIATE VENTILATOR ALARMS; (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT340 ADULT BREATHING CIRCUIT FAILED THE LEAK TEST ON THE RESPIRATOR. THEY FURTHER STATED THAT A PIN HOLE WAS FOUND ON THE DRYLINE . THIS WAS FOUND BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340 120127

    Patients

    Seq Age Sex Outcome Treatment
    1 DRAGER EVITA 4 RESPIRATOR