BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 4283060 · Received November 27, 2014

    Report

    Report Number
    9611451-2014-00891
    Event Type
    Malfunction
    Date Received
    November 27, 2014
    Date of Event
    October 28, 2014
    Report Date
    October 30, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE IN THE PROCESS OF OBTAINING THE COMPLAINT DEVICE FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT DEVICE WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THEREFORE, OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL, PREVIOUS SIMILAR INVESTIGATIONS AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: INSPECTION OF THE PHOTOGRAPH PROVIDED BY THE HOSPITAL REVEALED THAT THE SWIVEL WYE WAS CRACKED. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT 131015. CONCLUSION: WITHOUT THE RETURN OF THE COMPLAINT DEVICE WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED PROBLEM. IF THE COMPLAINT DEVICE WAS RETURNED IT WOULD HAVE BEEN VISUALLY INSPECTED AND PRESSURE TESTED FOR LEAK. ALL RT236 INFANT EVAQUA BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE AND FLOW TESTED PRIOR TO BE RELEASED FOR DISTRIBUTION. ANY CIRCUITS THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE SUBJECT BREATHING CIRCUIT WAS DAMAGED AFTER IT WAS RELEASED FOR DISTRIBUTION. THE HOSPITAL FURTHER REPORTED THAT THE CIRCUIT PASSED THE LEAK TEST ON THE VENTILATOR PRIOR TO PATIENT USE. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT236 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."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT THE SWIVEL WYE ON AN RT236 INFANT DUAL HEATED EVAQUA BREATHING CIRCUIT WAS DAMAGED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT THE SWIVEL WYE ON AN RT236 INFANT DUAL HEATED EVAQUA BREATHING CIRCUIT WAS DAMAGED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770255 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT236 131015

    Patients

    Seq Age Sex Outcome Treatment
    1