BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 1001388 · Received February 23, 2008

    Report

    Report Number
    9611451-2008-00068
    Event Type
    Malfunction
    Date Received
    February 23, 2008
    Report Date
    January 24, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER AND PAYKEL HEALTHCARE BY A HOSPITAL. THE PRODUCT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. ADD'L LOT NUMBER IS 071012, MFR DATE 10/12/2007. THE RESISTANCE OF THE HEATER WIRE ON BOTH THE INSPIRATORY AND EXPIRATORY LIMBS OF ALL 7 RETURNED CIRCUITS WERE MEASURED. RESULTS: THE RESULTS OF THESE TESTS SHOW THAT EITHER THE INSPIRATORY OR EXPIRATORY HEATER WIRE RESISTANCE OR SOMETIMES BOTH WERE OUTSIDE THE SPECIFICATION, ALWAYS ON THE HIGH SIDE. HIGHER RESISTANCES ARE USUALLY ASSOCIATED WITH IMPROPER PINNING OF THE HEATER WIRES. OUR RECORDS INDICATE THAT ONE OTHER COMPLAINT (TOTAL TWO COMPLAINTS) OF THIS NATURE HAS BEEN RECEIVED FOR THE GIVEN LOT NUMBER (0710102). CONCLUSIONS: THE CIRCUITS ARE OUT OF SPECIFICATION. THERE HAVE BEEN CHANGES MADE TO THE PINNING PROCESS RECENTLY THROUGH THE REPLACEMENT OF ALL THE PINNING MACHINES ON THE PRODUCTION LINE. THE EFFECTIVE DATE FOR THIS IMPROVEMENT IS FOR ALL PRODUCT MANUFACTURED AFTER 11/29/2007. ALL OF THE ABOVE PRODUCT WAS MANUFACTURED BEFORE THE DATE OF THE CORRECTIVE ACTION. OUR MONITORING AND TRENDING FOR THIS TYPE OF EVENT HAS A RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YEAR OF 0.0022%.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED TO OUR DISTRIBUTOR THAT 7 RT200 ADULT BREATHING CIRCUITS HAD A HEATER WIRE RESISTANCE VALUE THAT IS NOT NORMAL. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE BTT FISHER & PAYKEL HEALTHCARE, LTD. RT200 071009

    Patients

    Seq Age Sex Outcome Treatment
    1