BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED BREATHING CIRCUIT

    MDR report key: 2182894 · Received July 28, 2011

    Report

    Report Number
    9611451-2011-00453
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Report Date
    July 1, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    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). PMA/510(K): THE RT200 ADULT DUAL-HEATED BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K983112. METHOD: THE ELECTRICAL RESISTANCE OF THE HEATER WIRES IN THE INSPIRATORY AND THE EXPIRATORY TUBES OF THE RETURNED RT200 ADULT BREATHING CIRCUIT WERE TESTED USING A MULTIMETER. A CONTINUITY TEST WAS USED TO LOCATE THE BREAK IN THE HEATER WIRES. RESULTS: NO FAULT WAS FOUND WITH THE HEATER WIRE IN THE EXPIRATORY TUBE. THE INSPIRATORY HEATER WIRE WAS OPEN CIRCUIT DUE TO A BREAK IN CONNECTION BETWEEN THE HEATER WIRE AND ONE OF THE PINS THAT CRIMPS TO THE HEATER WIRE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 101213. 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).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE WAS A HEATING ISSUE WITH AN RT200 ADULT DUAL-HEATED BREATHING CIRCUIT. AN ALARM SOUNDED WHEN IT WAS CONNECTED TO THE MR850AEA RESPIRATORY HUMIDIFIER. THIS WAS NOTICED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT200 101213

    Patients

    Seq Age Sex Outcome Treatment
    1