BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 3069861 · Received April 22, 2013

    Report

    Report Number
    9611451-2013-00309
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 26, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT225 INFANT BIAS FLOW BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4). IT WAS VISUALLY INSPECTED FOR DAMAGE AND PRESSURE TESTED FOR LEAKS. RESULTS: NO PHYSICAL DAMAGE WAS OBSERVED TO THE COMPLAINT BREATHING CIRCUIT. THE PRESSURE TEST REVEALED THAT THE COMPLAINT CIRCUIT WAS WITHIN SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT 120724. CONCLUSION: NO FAULT WAS FOUND WITH THE COMPLAINT BREATHING CIRCUIT. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT225 INFANT BIAS FLOW BREATHING CIRCUIT 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). THE COMPLAINT RT225 BREATHING CIRCUIT IS CURRENTLY EN ROUTE TO FISHER & PAYKEL (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 THAT AN RT225 INFANT BIAS FLOW BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT225 INFANT BIAS FLOW BREATHING CIRCUIT FAILED THE VENTILATOR LEAK TEST. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173049 INFANT BIAS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT225 120724

    Patients

    Seq Age Sex Outcome Treatment
    1