BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 3855007 · Received June 9, 2014

    Report

    Report Number
    9611451-2014-00494
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Report Date
    May 8, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT200 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. METHOD: THE COMPLAINT RT200 ADULT DUAL HEATED BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEATLHCARE IN (B)(4) WHERE IT WAS VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAK. RESULTS: VISUAL INSPECTION REVEALED NO DAMAGE TO THE RETURNED BREATHING CIRCUIT. PRESSURE TEST REVEALED THAT THE BREATHING CIRCUIT WAS WITHIN SPECIFICATION. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE LEAK REPORTED BY THE CUSTOMER AS NO FAULT WAS FOUND WITH THE RETURNED COMPLAINT DEVICE. A LEAK IN THE BREATHING CIRCUIT IS USUALLY DETECTED BY AN ALARM ON THE VENTILATOR. ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THE USER INSTRUCTIONS THAT ACCOMPANY THE DEVICE STATE: CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE. SET APPROPRIATE VENTILATOR ALARMS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT200 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. THE COMPLAINT DEVICE IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE EXPIRATORY TUBE OF AN RT200 ADULT DUAL HEATED BREATHING CIRCUIT WAS LEAKING. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE EXPIRATORY TUBE OF AN RT200 ADULT DUAL HEATED BREATHING CIRCUIT WAS LEAKING. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334674 ADULT DUAL HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT200 1311010301

    Patients

    Seq Age Sex Outcome Treatment
    1