BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 1565789 · Received December 22, 2009

    Report

    Report Number
    9611451-2009-00706
    Event Type
    Malfunction
    Date Received
    December 22, 2009
    Date of Event
    November 22, 2009
    Report Date
    November 23, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BZE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER & PAYKEL HEALTHCARE (FPH) BY A HOSPITAL IN THE (B)(6). THE PRODUCT IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K893112. THE COMPLAINT RT340 ADULT BREATHING CIRCUIT WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) (B)(4) FOR INVESTIGATION. WE ARE CURRENTLY OBTAINING FURTHER INFO TO ASSIST US WITH ANALYSIS AND IDENTIFICATION OF A POSSIBLE ROOT CAUSE OF THE REPORTED EVENT. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE INFO REQUESTED AND HAVE COMPLETED OUR ANALYSIS.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED TO FISHER & PAYKEL HEALTHCARE (FPH) FIELD REP THAT WHILE AN RT340 ADULT BREATHING CIRCUIT WAS BEING USED ON A PT, THE "EXPIRATORY LIMB HAD COLLAPSED WHILE THE PT WAS BEING VENTED (UNCONFIRMED)". IT WAS ALSO REPORTED THAT BOTH THE MAQUET SERVO I VENTILATOR AND AN MR850 RESPIRATORY HUMIDIFIER, THAT WERE ALSO USED DURING THE REPORTED INCIDENT, HAD BEEN TAKEN OUT OF SERVICE. THE COMPLAINT BREATHING CIRCUIT HAD BEEN DESTROYED AT THE HOSPITAL. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 MAQUET SERVO I VENTILATOR| MR850 RESPIRATORY HUMIDIFIER