BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SORVALL

    MDR report key: 1820642 · Received August 16, 2010

    Report

    Report Number
    1820642
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    THERMO FISHER SCIENTIFIC
    Product Code
    JQC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A TREND THAT WE ARE SEEING IS ON THE REPAIRS OF A PARTICULAR MODEL OF CENTRIFUGES PURCHASED AROUND THE END OF 2008, PURCHASED AND USED BY THE LABORATORY IN THE HEALTH CARE SYSTEM.THE WARRANTY HAS ALREADY EXPIRED AND WE ARE SEEING AN INCREASED AMOUNT OF THESE DEVICES COME INTO OUR SHOP. WE CURRENTLY HAVE TWO IN OUR SHOP FOR REPAIR.THE CENTRIFUGES WERE PURCHASED TO REPLACE OLDER ONES THAT ARE NOW OBSOLETE AND OUT OF DATE. THE NEW MACHINE APPEARS TO BE A POOR DESIGN AND INFERIOR QUALITY. WE HAVE HAD A RASH OF REPAIRS ON THESE, SOME CAUSED BY USER DAMAGE DUE TO POOR DESIGN. NOT SURE IF THEY WERE BUILT TO HANDLE THE WORK LOAD THAT THIS FACILITY PLACES ON THESE DEVICES.OURS IS THE NON-REFRIGERATED TYPE, THE T1. RT1 = REFRIGERATED.THERMO SCIENTIFIC* SORVALL* LEGEND* T1/RT1 CENTRIFUGES SYSTEM: LABORATORY, CENTRIFUGES====================== HEALTH PROFESSIONAL'S IMPRESSION======================CTS HAS IDENTIFIED A TREND IN THIS PARTICULAR EQUIPMENT REQUIRING REPAIRS FREQUENTLY. NEW MACHINES APPEAR TO BE POORLY DESIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SORVALL CENTRIFUGE TABLE-TOP-10-780A JQC THERMO FISHER SCIENTIFIC SORVALL T1 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 *