BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3904385

    MDR report key: 3904385 · Received June 26, 2014

    Report

    Report Number
    3904385
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    April 13, 2014
    Report Date
    June 26, 2014
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS A CARDIAC EVENT ARREST AT HOME AND WAS PLACED ON HYPOTHERMIA PROTOCOL. EF 20%, MAXED ON MULTIPLE VASOACTIVE GTTS (NEO 300, EPI 10, DOPAMINE 20, LEVO 30). IN AM BP IN 70'S, ATTEMPTING TO REWARM PATIENT. PATIENT WAS NORMOTHERMIC AT 1200. AT 1500 WAS BATHING PATIENT/REMOVING COOLING VEST AND WAS NOTED TO HAVE SMALL SEROUS FILLED BLISTERS TO LEFT BACK/FLANK. NO OTHER SKIN ISSUES NOTED BESIDES THIS ONE AREA. HAIR WASHED WITHOUT SCALP LESIONS. BATHING WAS COMPLETED. MD NOTIFIED, AND WOUND TEAM CONSULT PLACED.

    Patients

    Seq Age Sex Outcome Treatment
    0 70 YR