BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SNUGGLE WARM PATIENT WARMING BLANKET

    MDR report key: 7071930 · Received November 30, 2017

    Report

    Report Number
    7071930
    Event Type
    Injury
    Date Received
    November 30, 2017
    Date of Event
    October 23, 2017
    Report Date
    December 8, 2017
    Manufacturer
    SMITH MEDICAL
    Product Code
    DWJ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2017, A (B)(6) Y/O PT WENT TO THE OPERATING ROOM FOR A TOTAL LEFT TOTAL HIP ARTHROPLASTY, IT IS REPORTED THE SURGERY WENT WELL BUT WHEN THEY OPERATING ROOM CREW REMOVED THE WARMING BLANKET FROM TOP OF THE PT, THERE WERE SMALL PALE RED SPOTS ON THE PT'S LEFT FOREARM RELATED TO THE BODY WARMER. SPOTS WERE GETTING LIGHTER IN COLOR UPON ARRIVAL TO THE RECOVERY ROOM. RISK BECAME AWARE OF THE EVENT ON (B)(6) 2017 AT WHICH TIME THE WARMING UNIT WAS SEQUESTERED WHEN DISCOVERED THE UNIT USED. UNFORTUNATELY THE WARMING BLANKET WAS NOT SAVED. THE DELAY IN REPORTING THE EVENT IS DUE TO WAITING TO SEE IF THE WARMING BLANKET OR WARMING UNIT REQUIRED THE MED-WATCH. RISK HAD THE WARMING UNIT CHECKED TO SEE IF THE UNIT WAS FUNCTIONING PROPERLY. THE WARMING UNIT WAS CHECKED AND FOUND TO BE FUNCTIONING IN THE PARAMETERS LISTED BY BIOMED / MANUFACTURER. LEAVING THE MED-WATCH NEEDED FOR THE WARMING BLANKET. THERE IS NO DOCUMENTATION AS TO THE REDNESS IN THE PT'S CHART AND THE PT WAS DISCHARGED HOME ON (B)(6) 2017.

    Description of Event or Problem · 1

    THIS WAS ORIGINALLY SENT ON 11/15/2017 BUT RETURNED UNOPENED TO RISK MANAGEMENT ON 12/05/2017. FOUND THE CORRECT ADDRESS FOR SMITH MEDICAL FROM OUR CENTRAL STORES DEPARTMENT AND RESENDING THIS TO THE CORRECT ADDRESS. ORIGINALLY SENT TO SMITH MEDICAL ASD, INC. IN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852688 SNUGGLE WARM PATIENT WARMING BLANKET WARMING BLANKET DWJ SMITH MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR