BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2720164 · Received August 29, 2012

    Report

    Report Number
    9611451-2012-00586
    Event Type
    Malfunction
    Date Received
    August 29, 2012
    Date of Event
    July 12, 2012
    Report Date
    August 3, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. LOT NUMBER AND DEVICE MANUFACTURER DATE: 120407 X 1, 111021 X 1; DEVICE MANUFACTURER DATE: 120407 - 07 APRIL 2012, 111021 - 21 OCTOBER 2011. METHOD: THE EXPIRATORY LIMBS OF BOTH COMPLAINT DEVICES WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR INSPECTION. RESULTS: VISUAL INSPECTION REVEALED THAT THE FIRST COMPLAINT DEVICE (LOT 120427) APPEARED TO HAVE BEEN PULLED AT ABOUT 3.5 CM FROM THE PATIENT END CONNECTOR. THE SECOND COMPLAINT DEVICE (LOT 111021) HAD A HOLE AT ABOUT 10 CM FROM THE ELBOW CONNECTOR OF THE EXPIRATORY LIMB PRESSURE TEST REVEALED THAT BOTH COMPLAINT DEVICES HAD EXCESSIVE LEAKS, WHICH WERE OUTSIDE OF THE SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS TYPE FOR LOT NUMBERS 120407 AND 111021. CONCLUSION: THE CAUSE OF THE REPORTED FAULT FOR THE FIRST COMPLAINT DEVICE IS THE EXPIRATORY LIMB HAVING BEEN PULLED. THE HOLE ON THE SECOND COMPLAINT DEVICE INDICATED THAT THE EXPIRATORY LIMB WAS PUNCTURED OR SCRATCHED WITH A BLUNT OBJECT. ALL BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED PRIOR TO LEAVING THE PRODUCTION LINE. ANY BREATHING CIRCUITS THAT FAIL ARE REJECTED. 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).

    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, WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. LOT NUMBER AND DEVICE MANUFACTURER DATE: 120407 X 1, 111021 X 1. DEVICE MANUFACTURER DATE: 120407 - 07 APRIL 2012, 111021 - 21 OCTOBER 2011. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING THE COMPLAINT DEVICES FROM THE HOSPITAL. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE COMPLAINT DEVICES AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT TWO RT340 BREATHING CIRCUITS WERE LEAKING. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT TWO RT340 BREATHING CIRCUITS WERE LEAKING. THIS WAS FOUND PRIOR TO 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 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1