BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMMERCIAL MEDICATION REFRIGERATOR

    MDR report key: 757603 · Received July 25, 2006

    Report

    Report Number
    MW1039835
    Event Type
    Malfunction
    Date Received
    July 25, 2006
    Date of Event
    May 15, 2006
    Report Date
    July 25, 2006
    Manufacturer
    BARNSTEAD
    Product Code
    KSE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    REFRIGERATOR DOES NOT MAINTAIN APPROPRIATE TEMPERATURE REQUIRED FOR VACCINES. COMVAX HEP A, HEP B, PREVNAR AND PPD HAD TO BE ISOLATED AND DESTROYED DUE TO THE POTENTIAL FOR DECREASED EFFICENCY AND/OR STABILITY OF THE STORAGE TEMPERATURE NOT MAINTAINED IN THE REFRIGERATOR. THE TOP HINGE ON REFRIGERATOR DISENGAGED, NOT ALLOWING DOOR TO CLOSE AND LOWER HINGE DISENGAGED AS WELL..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMMERCIAL MEDICATION REFRIGERATOR MEDICATION REFRIGERATOR KSE BARNSTEAD 3398G120A *

    Patients

    Seq Age Sex Outcome Treatment
    1 *