BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVCO ULTIMA SERIES

    MDR report key: 4146566 · Received September 29, 2014

    Report

    Report Number
    4146566
    Event Type
    Malfunction
    Date Received
    September 29, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 29, 2014
    Manufacturer
    THERMO FISHER SCIENTIFIC (ASHEVILLE), LLC
    Product Code
    JRM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    BONE FREEZER NOT MAINTAINING PROPER TEMPERATURE. SERVICE COMPANY CAME OUT TO EVALUATE PROBLEM, GAVE HIGH DOLLAR ESTIMATE TO REBUILD COMPRESSORS IN FREEZER. BIOMED CONTACTED MANUFACTURER WHO IS GOING TO REBUILD THE COMPRESSORS AT A MUCH LOWER COST. THIS UNIT IS 6.5 YRS OLD AND THIS HAS BEEN AN ONGOING PROBLEM AS WELL AS WITH OTHER ISSUES. SERVICE COMPANY COMES OUT TO EVALUATE ISSUES WITH HISTORY OF REPLACING PARTS WITH NO DEFINITIVE PROBLEM IDENTIFIED OR SOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604198 REVCO ULTIMA SERIES FREEZER JRM THERMO FISHER SCIENTIFIC (ASHEVILLE), LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *