BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT HEATED BREATHING CIRCUIT

    MDR report key: 2851364 · Received November 29, 2012

    Report

    Report Number
    9611451-2012-00868
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K100554
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE COMPLAINT RT241 BREATHING CIRCUIT IS IN TRANSIT TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE COMPLAINT DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT241 BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND A HEATER WIRE CONTINUITY TEST WAS PERFORMED WITH A CALIBRATED MULTIMETER. RESULTS: THE COMPLAINT DEVICE DID NOT PASS THE HEATER WIRE CONTINUITY TEST. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS TYPE FOR LOT NUMBER 120306. CONCLUSION: THE HEATER WIRE OF THE COMPLAINT DEVICE WAS FOUND TO BE OPEN CIRCUIT. WE WERE UNABLE TO DETERMINE THE CAUSE OF THE OPEN CIRCUIT. RESISTANCE TESTS AND VISUAL INSPECTIONS ARE PERFORMED ON ALL BREATHING CIRCUITS DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN RT241 ADULT BREATHING CIRCUITED CAUSED AN ALARM ON A MR880 HUMIDIFIER, APPROXIMATELY 30-40 MINUTES AFTER USE. THE ALARM WAS RESOLVED AFTER THE BREATHING CIRCUIT WAS CHANGED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED THAT AN RT241 ADULT BREATHING CIRCUITED CAUSED AN ALARM ON A MR880 HUMIDIFIER, APPROXIMATELY 30-40 MINUTES AFTER USE. THE ALARM WAS RESOLVED AFTER THE BREATHING CIRCUIT WAS CHANGED. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT HEATED BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT241 120306

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL HEALTHCARE MR880 RESP. HUMIDIFIER| FISHER & PAYKEL HEALTHCARE MR880 RESP. HUMIDIFIER