BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 1590466 · Received January 27, 2010

    Report

    Report Number
    9611451-2010-00038
    Event Type
    Malfunction
    Date Received
    January 27, 2010
    Date of Event
    December 22, 2009
    Report Date
    December 22, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT125 BREATHING CIRCUIT IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510 (K) NUMBER OF THE SIMILAR PRODUCT IS K20332. METHOD: THE RETURNED RT125 BREATHING CIRCUIT WAS VISUALLY INSPECTED FOR HOLES. RESULTS: A SMALL HOLE WAS FOUND IN THE INSPIRATORY TUBE OF THE BREATHING CIRCUIT. THE HOLE APPEARED TO BE MADE BY A THIN, SHARP OBJECT. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 090302. CONCLUSION: 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. FURTHERMORE, THE BREATHING CIRCUIT BEGAN LEAKING AFTER ONE DAY OF USE. THIS SUGGESTS THAT THE BREATHING CIRCUIT WAS PUNCTURED DURING USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT125 INFANT BIAS FLOW BREATHING CIRCUIT LEAKED AFTER ONE DAY OF USE. THE HOSPITAL REPORTED THAT THERE WAS A PINHOLE IN THE TUBE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT125 090302

    Patients

    Seq Age Sex Outcome Treatment
    1