BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 1467696 · Received May 30, 2009

    Report

    Report Number
    9611451-2009-00280
    Event Type
    Malfunction
    Date Received
    May 30, 2009
    Date of Event
    April 30, 2009
    Report Date
    May 4, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT DATES AND CORRESPONDING DEVICE MANUFACTURE DATES ARE AS FOLLOWS: LOT 081212-12/12/2008, LOT 081218-12/18/2008, LOT 080903-09/03/2008, LOT 080904-09/04/2008, LOT 081128-11/28/2008, LOT 080604-06/04/2008. FISHER & PAYKEL HEALTHCARE ('FPH') IS INFORMED THAT THE SUBJECT RT340 BREATHING CIRCUIT WHICH HAD FAILED THE VENTILATOR LEAK TEST UPON SET-UP HAD BEEN DISCARDED BY THE ATTENDING NURSE. THE HEALTHCARE FACILITY WILL BE FORWARDING A NUMBER OF UNOPENED PRODUCT WITH THE ABOVEMENTIONED LOT DATES TO FPH FOR TESTING. FPH IS NOT YET IN RECEIPT OF THE ABOVE DEVICES. WE WILL SUBMIT A FOLLOW-UP REPORT WITH OUR FINDINGS FOLLOWING RECEIPT OF THE PRODUCT AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY REPORTED THAT HOLES OF APPROXIMATELY 1 - 3MM IN DIAMETER WERE DETECTED IN THE CONNECTORS OF A NUMBER OF RT340 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUITS. ONE OF THE BREATHING CIRCUITS APPEARED TO HAVE FAILED THE VENTILATOR LEAK TEST DURING INITIAL EQUIPMENT SET UP. THE LEAK WAS DETECTED PRIOR TO PT USE. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE, LTD. RT340 081216

    Patients

    Seq Age Sex Outcome Treatment
    1