BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT

    MDR report key: 1670219 · Received April 26, 2010

    Report

    Report Number
    9611451-2010-00248
    Event Type
    Malfunction
    Date Received
    April 26, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 6, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT DATES AND CORRESPONDING DEVICE MANUFACTURE DATES OF THE COMPLAINT DEVICES: 090505 - 05/05/2009 (2 DEVICES); 090909 - 09/09/2009; 090827 - 08/27/2009; 090820 - 08/20/2009; 090817 - 08/17/2009. THE COMPLAINT RT235 ARE CURRENTLY EN ROUTE TO FISHER AND PAYKEL HEALTHCARE IN (B)(4) FOR TESTING. WE WILL SUBMIT OUR FINDINGS IN A FOLLOW-UP REPORT FOLLOWING RECEIPT OF THE SAID DEVICES AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA FISHER AND PAYKEL HEALTHCARE'S REGIONAL OFFICE IN (B)(4) THAT A QUANTITY OF 7 RT235 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUITS OUT OF A BATCH OF 20 APPEARED TO LEAK. THE ALLEGED LEAKS WERE DETECTED PRIOR TO PATIENT CONNECTION. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL-HEATED EVAQUA BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE LTD RT235 090820

    Patients

    Seq Age Sex Outcome Treatment
    1