BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED BREATHING CIRCUIT

    MDR report key: 2018618 · Received March 14, 2011

    Report

    Report Number
    9611451-2011-00158
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 17, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K). THE PRODUCT 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. MANUFACTURER NARRATIVE THE COMPLAINT RT200 ADULT DUAL-HEATED BREATHING CIRCUIT HAS ONLY RECENTLY BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE AND IS CURRENTLY BEING INVESTIGATED. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(6). PMA/510(K) THE PRODUCT 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. MANUFACTURER NARRATIVE METHOD: ONLY THE INSPIRATORY TUBE OF THE AFFECTED RT200 ADULT DUAL-HEATED BREATHING CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR INSPECTION. THE ELECTRICAL RESISTANCE OF THE INSPIRATORY HEATER WIRE WAS TESTED USING A MULTIMETER. RESULTS: THE ELECTRICAL RESISTANCE OF THE INSPIRATORY HEATER WIRE WAS OUTSIDE THE REQUIRED SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100927. CONCLUSION: THE ELECTRICAL RESISTANCE OF THE HEATER WIRE WAS FOUND TO BE OUTSIDE THE SPECIFICATION. THE ROOT CAUSE OF THIS FAULT COULD NOT BE DETERMINED. ALL BREATHING CIRCUITS ARE ELECTRICALLY TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THE HEATER WIRE BECAME FAULTY POST PRODUCTION. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT200 ADULT DUAL-HEATED BREATHING CIRCUIT BECAME OPEN CIRCUIT WHILE BEING USED ON A PATIENT. AN ALARM SOUNDED ON THE MR850 RESPIRATORY HUMIDIFIER. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT200 ADULT DUAL-HEATED BREATHING CIRCUIT BECAME OPEN CIRCUIT WHILE BEING USED ON A PATIENT. AN ALARM SOUNDED ON THE MR850 RESPIRATORY HUMIDIFIER. 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 100927

    Patients

    Seq Age Sex Outcome Treatment
    1