BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 3433764 · Received October 28, 2013

    Report

    Report Number
    9611451-2013-00850
    Event Type
    Malfunction
    Date Received
    October 28, 2013
    Date of Event
    September 30, 2013
    Report Date
    October 3, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR INSPECTION. THE ELECTRICAL RESISTANCE OF THE INSPIRATORY AND THE EXPIRATORY HEATERWIRES WERE TESTED USING A CALIBRATED MULTIMETER. CONTINUITY TEST AND VISUAL INSPECTION WERE ALSO CONDUCTED TO CHECK THE ELECTRICAL CONNECTION BETWEEN THE HEATERWIRES AND THE HEATERWIRE PINS. RESULTS: ELECTRICAL RESISTANCE TEST SHOWED THE EXPIRATORY HEATERWIRE WAS WITHIN SPECIFICATION; HOWEVER, THE INSPIRATORY HEATERWIRE WAS OPEN CIRCUIT. CONTINUITY TEST AND VISUAL INSPECTION REVEALED THAT THE OPEN CIRCUIT IN THE INSPIRATORY HEATERWIRE WAS LOCATED AT THE CONNECTION BETWEEN THE HEATERWIRE AND THE LEFT HEATERWIRE PIN INSIDE THE OVERMOULDED PLUG. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130624. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATERWIRES CAN BE ASSOCIATED WITH INSUFFICIENT CONNECTION OF THE HEATERWIRE PIN DURING PRODUCTION, SUCH THAT IT IS UNABLE TO PROVIDE CONTINUITY FOR THE FULL PERIOD OF USE. ALL RT340 BREATHING CIRCUITS ARE RESISTANCE AND CONTINUITY TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE SUBJECT INSPIRATORY HEATERWIRE BECAME OPEN CIRCUIT AFTER RELEASED FOR DISTRIBUTION, POSSIBLY AS A RESULT OF INSUFFICIENT CONNECTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6), REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A "HEATERWIRE DISCONNECT" ALARM SOUNDED ON THE MR850 RESPIRATORY HUMIDIFIER WHEN AN RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT WAS CONNECTED. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A "HEATERWIRE DISCONNECT" ALARM SOUNDED ON THE MR850 RESPIRATORY HUMIDIFIEIR WHEN AN RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT WAS CONNECTED. THIS WAS OBSERVED BEFORE USE ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552207 ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340 130624

    Patients

    Seq Age Sex Outcome Treatment
    1 MR850 RESPIRATORY HUMIDIFIER| MR850 RESPIRATORY HUMIDIFIER