BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 4244605 · Received November 11, 2014

    Report

    Report Number
    9611451-2014-00857
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 21, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT125 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INSPECTION. THE BREATHING CIRCUIT WAS VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: VISUAL INSPECTION REVEALED A CRACK IN THE SWIVEL WYE AND SCUFF MARKS ON THE RIM OF THE CONNECTOR. THE CIRCUIT WAS PRESSURE TESTED AND REVEALED THAT IT WAS WITHIN SPECIFICATION, WITH REGARD TO LEAK. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT 140409. CONCLUSION: WE WERE UNABLE TO DETERMINE DEFINITIVELY THE ROOT CAUSE OF THE CRACKING; HOWEVER, BASED ON THE VISUAL INSPECTION, THE RT125 BREATHING CIRCUIT APPEARS TO BE PHYSICALLY DAMAGED. ALL RT125 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAKS BEFORE RELEASING FOR DISTRIBUTION. ALSO THE SWIVEL ASSEMBLY IS PRESSURE AND FLOW TESTED AS PART OF THE INFANT BREATHING CIRCUIT AT THE PRODUCTION LINE BEFORE IT LEAVES THE FACTORY. ANY BREATHING CIRCUIT WHICH FAILS ANY OF THESE TESTS IS DISCARDED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE SWIVEL WYE OF AN RT125 INFANT BIAS FLOW BREATHING CIRCUIT WAS CRACKED.THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725776 INFANT BIAS FLOW BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT125 140409

    Patients

    Seq Age Sex Outcome Treatment
    1