BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLUTION WARMER

    MDR report key: 5401402 · Received February 1, 2016

    Report

    Report Number
    5401402
    Event Type
    Malfunction
    Date Received
    February 1, 2016
    Date of Event
    January 25, 2016
    Report Date
    January 27, 2016
    Manufacturer
    O.R. SOLUTIONS INC
    Product Code
    LHC
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WILE CLEANING POST OPERATIVELY, NOTICED A HOLE ON THE DRAPE OF THE SOLUTION WARMER USED ON THE CASE WHEN SHE WAS DRAINING THE SOLUTION FROM IT. THE DRAPE APPEARED TO HAVE MELTED FROM THE HEAT. CLINICAL ENGINEERING PROVIDED THE FOLLOWING UPDATE: THIS EVENT IS RELATED TO AN OPERATING ROOM SOLUTIONS WARMER MODEL ORS2094RE. UNABLE TO DUPLICATE PROBLEM, RAN UNIT FOR 8 HOURS AT 120 DEGREES AND UNIT OPERATED TO MANUFACTURER'S SPECIFICATIONS. THE UNIT TESTED FINE DURING THE EVALUATION; HOWEVER, THIS IS THE SECOND TIME IN 5 MONTHS THAT THIS HAS HAPPENED WITH THIS PARTICULAR WARMER. RECOMMEND SENDING THE UNIT INTO OPERATING ROOM SOLUTIONS FOR A MORE COMPREHENSIVE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60783 SOLUTION WARMER SOLUTION WARMER LHC O.R. SOLUTIONS INC ORS2094RE

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR