BEUDAMED
    FDA Adverse Event Other Summary report: N

    INCUBATOR/FLUID WARMER

    MDR report key: 32040 · Received February 22, 1996

    Report

    Report Number
    32040
    Event Type
    Other
    Date Received
    February 22, 1996
    Date of Event
    May 30, 1995
    Report Date
    November 16, 1995
    Manufacturer
    ACKRAD LABORATORIES
    Product Code
    LGZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WITH STAB WOUNDS TO RIGHT CHEST AND LIVER WAS SEEN IN ER. IV FLUIDS THAT WERE WARMED IN THE INCUBATOR UNIT WERE STARTED IN LEFT ARM IV. PT COMPLAINED OF BURNING, AND THE IV WAS SHUT OFF. PT LATER DEVELOPED REDNESS AT THE IV SITE AND BLISTERS UP THE LEFT ARM. BIOMED CHECKED THE INCUBATOR AND FOUND IT WORKING PROPERLY AND TEMP TESTS MET MFR'S RECOMMENDATIONS. PT WAS TREATED FOR CELLULITIS AT THE IV SITE AND DISCHARGED TO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INCUBATOR/FLUID WARMER INCUBATOR/FLUID WARMER LGZ ACKRAD LABORATORIES 403 4275

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other