BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT

    MDR report key: 3072072 · Received April 22, 2013

    Report

    Report Number
    9611451-2013-00320
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 26, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. METHOD: THE COMPLAINT RT340 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) AND VISUALLY INSPECTED. RESULTS: A HOLE WAS FOUND IN THE EVAQUA (EXPIRATORY) LIMB OF THE COMPLAINT BREATHING CIRCUIT, APPROXIMATELY 7 CM AWAY FROM THE PATIENT END CONNECTOR. CONCLUSION: BASED ON INSPECTION OF THE DAMAGE, IT IS LIKELY THAT THE EVAQUA EXPIRATORY LIMBS WERE PUNCTURED OR SCRATCHED BY A BLUNT OBJECT. ALL RT340 BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS PRIOR TO DISTRIBUTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE BREATHING CIRCUIT WAS DAMAGED POST-PRODUCTION, POSSIBLY DURING STORAGE OR SETUP. (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 A HOLE WAS FOUND ON THE EXPIRATORY LIMB OF AN RT340 ADULT BREATHING CIRCUIT. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171825 ADULT DUAL-HEATED WITH EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT340

    Patients

    Seq Age Sex Outcome Treatment
    1