BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2614315 · Received June 12, 2012

    Report

    Report Number
    9611451-2012-00385
    Event Type
    Malfunction
    Date Received
    June 12, 2012
    Date of Event
    May 14, 2012
    Report Date
    May 14, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER: 120208 (1); NOT PROVIDED (2). DEVICE MANUFACTURER DATE: 02/08/2012 (1). METHOD: TWO COMPLAINT INSPIRATORY LIMBS, NO LOT NUMBERS, WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE COMPLAINT INSPIRATORY LIMBS WERE BOTH VISUALLY INSPECTED AND PRESSURE TESTED. IF THE THIRD COMPLAINT INSPIRATORY LIMB, LOT 120208, HAD BEEN RETURNED TO THE MANUFACTURER, THE COMPLAINT DEVICE WOULD HAVE ALSO BEEN VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: NO PHYSICAL DAMAGES WERE OBSERVED ON THE TWO RETURNED COMPLAINT DEVICES. THE PRESSURE TEST REVEALED BOTH COMPLAINT INSPIRATORY LIMBS TO BE OPERATING WITHIN SPECIFICATION FOR THIS PRODUCT. NO FAULT WAS FOUND. A LOT CHECK COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED. CONCLUSION: NO FAULT WAS FOUND WITH BOTH COMPLAINT INSPIRATORY LIMBS AS THEY BOTH OPERATED WITHIN SPECIFICATION FOR THIS PRODUCT. ALTHOUGH WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE PROBLEM OBSERVED BY THE CUSTOMER, IT IS POSSIBLE THAT THE CONDENSATE LEAKED FROM THE BREATHING CIRCUIT. SMALL LEAKS OF THIS NATURE SHOULD BE DETECTED AND COMPENSATED FOR BY THE VENTILATOR. ALL CIRCUITS ARE PRESSURE TESTED BEFORE THEY ARE ALLOWED TO LEAVE THE PRODUCTION LINE. THIS IS AN AUTOMATED PROCESS AND THE CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THE RT235 USER INSTRUCTIONS STATE THE FOLLOWING: CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE; PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT; SET APPROPRIATE VENTILATOR ALARMS.

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER: 120208 (1), NOT PROVIDED (2). DEVICE MANUFACTURER DATE 02/08/2012 (1). THE COMPLAINT DEVICE IS EN ROUTE TO THE MANUFACTURER. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE IS WATER LEAKAGE AT THE HEATERWIRE CONNECTION OF THE INSPIRATORY LIMB OF THREE RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUITS DURING USE NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE IS WATER LEAKAGE AT THE HEATERWIRE CONNECTION OF THE INSPIRATORY LIMB OF THREE RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUITS DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT235 SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1