BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICHOICE WARMING BLANKET

    MDR report key: 2666339 · Received July 18, 2012

    Report

    Report Number
    MW5026247
    Event Type
    Malfunction
    Date Received
    July 18, 2012
    Date of Event
    June 11, 2012
    Report Date
    July 18, 2012
    Manufacturer
    *
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) MALE WAS ADMITTED FOR ELECTIVE AORTIC VALVE REPLACEMENT ON (B)(6) 2012 TO (B)(6) HOSPITAL. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE; HOWEVER, IN RECOVERY STAFF NOTICED THAT THERE WAS A WAFFLE LIKE PATTERN ON THE PT'S BACK THAT WAS THOUGHT TO BE CAUSED BY THE WARMING BLANKET USED DURING SURGERY. BURN LOCATION WAS PT'S UPPER BACK AND BURN PATTERN IS CONSISTENT WITH THE PATTERN WAFFLING ON THE MEDICHOICE HEATING BLANKET. NO BLISTERS OR DRAINAGE NOTED. SURGICAL ADMINISTRATIVE DIRECTOR NOTIFIED AND BIO MED NOTIFIED. IN ADDITION, MANAGER OF MATERIALS MANAGEMENT NOTIFIED. IT WAS LEARNED THAT WE RECENTLY SWITCHED VENDORS AND SURGERY STAFF ARE NOW USING THIS PRODUCT. NOTE IS TAKEN THIS IS THE SECOND INCIDENT OF A SIMILAR NATURE NOTED WITH THE USE OF THIS NEWLY ACQUIRED PRODUCT. USE OF SAID PRODUCT CEASED AFTER THIS EVENT AND SEARCH COMMENCED TO OBTAIN DIFFERENT PRODUCT. EVENT ABATED AFTER USE STOPPED: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICHOICE WARMING BLANKET WARMING BLANKET DWJ * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR