BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RT235 INFANT VENTILATOR CIRCUIT DUAL HEATED WITH MR290

    MDR report key: 2954108 · Received January 24, 2013

    Report

    Report Number
    MW5028892
    Event Type
    Injury
    Date Received
    January 24, 2013
    Date of Event
    December 16, 2012
    Report Date
    January 24, 2013
    Manufacturer
    FISHER PAYKEL
    Product Code
    BTT
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED FROM OUTLYING ED TO THE CARDIAC INTENSIVE CARE UNIT ON (B)(6) 2013 POST CARDIAC ARREST AND INTUBATION. PT ADMITTED WITH PROBABLE SEPTIC SHOCK AND SEVERE RIGHT VENTRICULAR FAILURE. PT PREPPED AND DRAPED FOR PLACEMENT OF VENOARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATOR. PT CANNULATED AND PLACED ON ECMO. POST DRAPING REMOVED AND NURSING NOTED A REDDENED AREA TO RIGHT LOWER ABDOMEN AND RIGHT UPPER THIGH CORRELATING TO WHERE THE VENTILATOR TUBING WAS IN CONTACT WITH THE PT'S SKIN. PT EVALUATED AND TREATED BY WOUND CARE TEAM. BOTH BURNS NOTED TO BE PARTIAL THICKNESS BURNS WITH THE RIGHT UPPER THIGH NOTED TO HAVE BLISTERED. WOUND CARE TEAM DISCONTINUED CARE FOR THE ABDOMINAL BURN ON (B)(6) 2013 AS THE BURN HAD HEALED. PT STILL UNDER CARE AT TIME OF DISCHARGE FOR BURN TO RIGHT UPPER THIGH AS BLISTER HAD OPENED AND WOUND WAS BEING CLEANED AND DRESSED. CARE OF PT WAS TRANSFERRED TO A FACILITY CLOSER TO PT'S HOME ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34593 RT235 INFANT VENTILATOR CIRCUIT DUAL HEATED WITH MR290 VENTILATOR CIRCUIT BTT FISHER PAYKEL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Required Intervention SERVO-I VENTILATOR