BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 1883609 · Received October 26, 2010

    Report

    Report Number
    9611451-2010-00644
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 1, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) THE 510(K) NUMBER: THE PRODUCT REFERRED TO IN THE EVENT DESCRIPTION IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. ALTHOUGH IT WAS REPORTED THAT THE BREATHING CIRCUIT WOULD BE RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION, THE CIRCUIT HAS NOT BEEN RECEIVED. WITHOUT THE RETURN OF THE CIRCUIT FOR ELECTRICAL TESTING, WE ARE UNABLE TO CONFIRM OR DETERMINE THE ROOT CAUSE OF THE REPORTED COMPLAINT. SHOULD THE CIRCUIT BE RETURNED FOR TESTING IN THE FUTURE, WE WILL FILE AN ADDITIONAL REPORT WITH OUR INVESTIGATION FINDINGS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT REFERRED TO IN THE EVENT DESCRIPTION IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. MANUFACTURER NARRATIVE: METHOD: THE ELECTRICAL RESISTANCE OF THE HEATER WIRE IN THE INSPIRATORY TUBE OF THE RETURNED RT212 BREATHING CIRCUIT WAS TESTED USING A MULTIMETER. RESULTS: ELECTRICAL RESISTANCE TESTING SHOWED THAT THE INSPIRATORY LIMB HEATER WIRE WAS OPEN CIRCUIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100409. CONCLUSION: ELECTRICAL OPEN CIRCUITS IN HEATER WIRES ARE OFTEN ASSOCIATED WITH IMPROPER CRIMPING OF THE HEATER WIRE DURING PRODUCTION. ALL BREATHING CIRCUITS ARE ELECTRICALLY TESTED DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THE TIMING OF USE SHOWS THAT THE HEATER WIRE BECAME AN OPEN CIRCUIT POST PRODUCTION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT REFERRED TO IN THE EVENT DESCRIPTION IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. THE COMPLAINT BREATHING CIRCUIT IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT212 ADULT BREATHING CIRCUIT DID NOT HEAT. THE BREATHING CIRCUIT WAS TESTED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT212 ADULT BREATHING CIRCUIT DID NOT HEAT. THE BREATHING CIRCUIT WAS TESTED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT AN RT212 ADULT BREATHING CIRCUIT DID NOT HEAT. THE BREATHING CIRCUIT WAS TESTED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT212 100409

    Patients

    Seq Age Sex Outcome Treatment
    1