BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2916631 · Received January 15, 2013

    Report

    Report Number
    9611451-2013-00043
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    July 16, 2012
    Report Date
    December 21, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT340 ADULT BREATHING CIRCUITS WERE RETURNED TO FPH IN (B)(4) AND VISUALLY INSPECTED FOR DAMAGE. RESULTS: VISUAL INSPECTION OF THE RETURNED BREATHING CIRCUITS REVEALED THAT EACH HAD A HOLE ON THE EVAQUA EXPIRATORY LIMB. THE LIMBS APPEARED TO HAVE BEEN PUNCTURED OR SCRATCHED WITH A BLUNT OBJECT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120810. CONCLUSION: ALL RT340 BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO DISTRIBUTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE EVAQUA EXPIRATORY LIMBS WERE DAMAGED POST PRODUCTION. (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." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(4) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) DISTRIBUTOR THAT TWO RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUITS EACH HAD A "RAP" ON THE EXPIRATORY LIMB. IT WAS FURTHER REPORTED THAT THE BREATHING CIRCUITS FAILED THE VENTILATOR LEAK TEST. THIS WAS OBSERVED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23050 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340 120810

    Patients

    Seq Age Sex Outcome Treatment
    1