BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVAQUA2

    MDR report key: 4192854 · Received October 16, 2014

    Report

    Report Number
    MW5038705
    Event Type
    Injury
    Date Received
    October 16, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    FISHER AND PAYKEL
    Product Code
    BZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    BIRTHING GA: (B)(6). CGA: (B)(6) INFANT RECEIVING NEONATAL INTENSIVE CARE INTUBATED AND VENTILATED CURRENTLY RECEIVING HELIOX THERAPY VIA MECHANICAL VENTILATION UTILIZING FISHER AND PAYKEL DISPOSABLE INFANT VENTILATOR CIRCUIT. PRODUCT INFO AS FOLLOWS; FISHER AND PAYKEL RESPIRATORY CARE SYSTEM EVAQUA2 REF # RT265 LOT NUMBER 140801. THIS CIRCUIT OVERHEATED, VERY HOT TO TOUCH. PT HEART RATE INCREASED TO 193BPM, RESPIRATORY RATE INCREASED TO 96 BPM AND CORE TEMPERATURE OF 38 C. POWER TO CIRCUIT DISABLED, CIRCUIT WAS REPLACED, PT RETURNED TO BASELINE HR, RR AND TEMPERATURE. WE WERE VERY CONCERNED THIS DISPOSABLE CIRCUIT WAS ABOUT TO MELT. DATES OF USE: (B)(6) 2014. DIAGNOSIS OR REASON FOR USE: LIFE SUPPORT MECHANICAL VENTILATION FOR CRITICALLY ILL PT. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED?: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659764 EVAQUA2 BREATHING CIRCUIT BZE FISHER AND PAYKEL RT 265 140801

    Patients

    Seq Age Sex Outcome Treatment
    1 74 DA Required Intervention