BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 2172758 · Received July 22, 2011

    Report

    Report Number
    9611451-2011-00429
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    June 21, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. MANUFACTURER NARRATIVE: METHOD: THE ELECTRICAL RESISTANCE OF THE HEATER WIRES IN BOTH THE INSPIRATORY AND THE EXPIRATORY TUBES OF THE RETURNED RT340 ADULT BREATHING CIRCUIT WAS TESTED USING A MULTIMETER. RESULTS: NO FAULT WAS FOUND WITH THE HEATER WIRE IN THE EXPIRATORY TUBE. THE ELECTRICAL RESISTANCE WAS WITHIN THE REQUIRED SPECIFICATION. HOWEVER, THE HEATER WIRE IN THE INSPIRATORY TUBE WAS OPEN CIRCUIT. A CONNECTION BREAK WAS FOUND BETWEEN THE HEATER WIRE AND THE HEATER WIRE PIN. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100512. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATER WIRES CAN BE ASSOCIATED WITH IMPROPER CRIMPING OF THE HEATER WIRE DURING PRODUCTION. ALL BREATHING CIRCUITS ARE ELECTRICALLY TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE HEATER WIRE BECAME OPEN CIRCUIT POST PRODUCTION, POSSIBLY AS A RESULT OF A WEAK CRIMP CONNECTION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. MANUFACTURER NARRATIVE: THE RT340 ADULT BREATHING CIRCUIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVED THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN ALARM SOUNDED ON THE MR850 RESPIRATORY HUMIDIFIER AFTER CONNECTING AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT. THIS WAS NOTICED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN ALARM SOUNDED ON THE MR850 RESPIRATORY HUMIDIFIER AFTER CONNECTING AN RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT. THIS WAS NOTICED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT340 100512

    Patients

    Seq Age Sex Outcome Treatment
    1