BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 2035671 · Received April 1, 2011

    Report

    Report Number
    9611451-2011-00213
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    December 19, 2010
    Report Date
    December 1, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).510(K):THE PRODUCT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K20332. THE COMPLAINT DEVICE HAS NOT YET BEEN RECEIVED FOR INVESTIGATION.WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K20332. NARRATIVE: METHOD: THE RETURNED BREATHING CIRCUIT WAS PRESSURE TESTED AND SUBMERGED IN A WATER BATH TO CHECK FOR LEAKS. RESULTS: THE BREATHING CIRCUIT WAS FOUND TO BE LEAKING FROM A HOLE IN THE INSPIRATORY EXTENSION AND EXPIRATORY LIMBS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 091103. CONCLUSION: ALL BREATHING CIRCUITS ARE PRESSURE TESTED FOR LEAKS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE LEAK DEVELOPED POST-PRODUCTION, POSSIBLY DURING TRANSPORT OR SET-UP. A LEAK IN THE BREATHING CIRCUIT IS USUALLY DETECTED BY AN ALARM ON THE VENTILATOR. THE RT125 USER INSTRUCTIONS THAT ACCOMPANY THE DEVICE STATE THE FOLLOWING WARNINGS: 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. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THERE WAS A LEAK IN AN RT125 BREATHING CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THERE WAS A LEAK IN AN RT125 BREATHING CIRCUIT.NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT125 091103

    Patients

    Seq Age Sex Outcome Treatment
    1