BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 2993668 · Received March 7, 2013

    Report

    Report Number
    9611451-2013-00168
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THAT PRODUCT IS K983112. CORRECTION: THE COMPLAINT DEVICES RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WERE 2 X RT200 ADULT DUAL-HEATED BREATHING CIRCUITS. UPON COMPLETING OUR INVESTIGATION IT WAS REVEALED THAT NO FAULT WAS FOUND WITH ONE OF THE RETURNED RT200 BREATHING CIRCUITS WHILE THE OTHER RT200 BREATHING CIRCUIT HAD BENT PINS. BENT PINS IS A NON MDR REPORTABLE COMPLAINT. REPORTING OF BENT PINS AS AN MDR WAS DISCONTINUED AS OF (B)(4) 2012 WITH GUIDANCE FROM (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY AWAITING THE RETURN OF THE COMPLAINT DEVICES FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TWO RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUITS FOR HEATER WIRE DISCONNECTED AND A FAULT WITH THE EXPIRATORY LIMB. UPON RECEIVING THE COMPLAINT DEVICES AT FISHER & PAYKEL HEALTHCARE IN (B)(4), IT WAS REVEALED THAT THEY WERE RT200 ADULT DUAL-HEATED BREATHING CIRCUITS. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TWO RT340 ADULT DUAL HEATED EVAQUA BREATHING CIRCUITS FOR HEATER WIRE DISCONNECTED AND A FAULT WITH THE EXPIRATORY LIMB. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98303 ADULT DUAL HEATED BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT200 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1