BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED BREATHING CIRCUIT

    MDR report key: 1558488 · Received December 8, 2009

    Report

    Report Number
    9611451-2009-00661
    Event Type
    Malfunction
    Date Received
    December 8, 2009
    Report Date
    November 13, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THEY FOUND PINHOLES IN TWO, (2) RT240 BREATHING CIRCUITS, BUT THEY PROVIDED THREE; (3) PRODUCT LOT NUMBERS. THE CUSTOMER WAS UNABLE TO SPECIFY WHICH OF THE LOT NUMBERS RELATE TO THE COMPLAINT BREATHING CIRCUITS. THE LOT NUMBERS AND ASSOCIATED DATES OF MANUFACTURE, AS REPORTED BY THE HOSPITAL, ARE AS FOLLOWS: LOT NUMBER: 090319, DEVICE MANUFACTURE DATE: 03/19/2009; 090703, 07/03/2009; 090824, 08/24/2009. THE COMPLAINT BREATHING CIRCUITS ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR ANALYSIS. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT TWO (2) RT240 ADULT DUAL HEATED BREATHING CIRCUITS FAILED THE LEAK TEST ON A SERVO-I VENTILATOR. THE HOSPITAL REPORTED THAT THEY FOUND SMALL PINHOLES IN THE BREATHING CIRCUITS. THE PINHOLES WERE DISCOVERED BEFORE PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL HEATED BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE, LTD. RT240

    Patients

    Seq Age Sex Outcome Treatment
    1 SIEMENS: MAQUET SERVO-I VENTILATOR