BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE DRAPE

    MDR report key: 489433 · Received October 17, 2003

    Report

    Report Number
    489433
    Event Type
    Malfunction
    Date Received
    October 17, 2003
    Date of Event
    March 1, 2003
    Report Date
    May 1, 2003
    Manufacturer
    OR SOLUTIONS, INC.
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CRACK NOTED IN PLASTIC PLATE OF DRAPE AFTER CASE COMPLETED. THIS IS THE THIRD INCIDENT OF PLATE DRAPE FAILURE. THERE WAS FIVE MACHINES UTILIZING THIS DEVICE WHICH ROTATE TO ALL OR SUITES. RESOLUTION - REPLACEMENT OF ALL HEATERS BY CO AND STAFF EDUCATION WAS INITIATED AND COMPLETED. FOLLOW-UP-ONGOING MONITORING OF WARMER SURFACE CORROSION/PITTING WITH PROMPT REPLACEMENT AS NEEDED. HEATER DEVICE FAILURE - CORROSION. COOLER DEVICE FAILURE - UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLATE DRAPE SOLUTION DRAPE - HUSH SLUSH KKX OR SOLUTIONS, INC. H3204102D *

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR