BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIZANT BAIR HUGGER WARMING UNIT

    MDR report key: 3233865 · Received July 12, 2013

    Report

    Report Number
    MW5030915
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    May 13, 2013
    Report Date
    July 12, 2013
    Manufacturer
    ARIZANT HEALTHCARE INC.
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED FOR SURGERY ON (B)(6) 2013 FOR LARYNGEAL/TRACHEAL RECONSTRUCTION WITH BRONCHOSCOPY AND LARYNGOSCOPY. SURGERY LASTED APPROXIMATELY 5 HOURS. POST PROCEDURE, PATIENT NOTED TO HAVE AREAS OF REDNESS TO BUTTOCKS, BACK AND OCCIPUT. WOUND CARE EVALUATED PATIENT AND FOUND SKIN TO BE INTACT AND SITES APPEAR TO BE HEALING. WOUND CARE WAS NOT INDICATED AT THAT TIME. WOUND CARE RE-CONSULTED ON (B)(6) 2013 ON DAY OF DISCHARGE. MINIMAL CHANGES NOTED SINCE PREVIOUS EVALUATION WITH OVERALL DECREASE IN SIZE AND NO OPEN AREAS. NO SKIN WOUND CARE INDICATED AT THIS TIME. FAMILY EDUCATED REGARDING CONTINUED SKIN CARE AND MAINTAINING MOIST WOUND HEALING USING AQUAPHOR OVER PINK AREAS. RECOMMEND FOLLOW-UP WITH M.D. ON DISCHARGE. PATIENT DISCHARGED ON (B)(6) 2013. PATIENT DIAGNOSED AT DISCHARGE WITH A SUPERFICIAL SECOND-DEGREE BURN ON BACK AND SCALP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321668 ARIZANT BAIR HUGGER WARMING UNIT BAIR HUGGER DWJ ARIZANT HEALTHCARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 21 MO Other ARTSORB SURGICAL TABLE COVERS: BY ADVANCE MEDICAL| DESIGNS INC, (B)(4)| BOVIE PAD: LOT #2511509| ELECTROSURGICAL UNIT ESU #4 TRIAD: (B)(4)