BEUDAMED
    FDA Adverse Event Summary report: N

    FORCE FX GENERATOR

    MDR report key: 277746 · Received May 10, 2000

    Report

    Report Number
    MW1018886
    Date Received
    May 10, 2000
    Manufacturer
    VALLEYLAB, INC.
    Product Code
    GEI
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PROBLEM: SURGERY PURCHASED AND USED VALLEY LAB FORCE FX GENERATOR. WHEN DELIVERED BIO-MED NOTED THAT THE SERIAL # TAG HAD BEEN REMOVED, OR WAS MISSING. VALLEYLAB STATED THEIR CO WOULD NOT DO THIS. THE EQUIPMENT WAS PURCHASED FROM: NORTHWEST SURGICAL PRODUCTS INC, RENO, NEVADA. WITH NO NUMBERS, THERE IS NO WAY TO TRACK EQUIPMENT OR KNOW IF ANY CHANGES HAVE BEEN MADE TO THE EQUIPMENT. EVEN THE DATE OF MFR IS NOT AVAILABLE. BASICALLY, THE POTENTIAL FOR PT INJURY, GIVEN THE AMOUNT OF USED EQUIPMENT AVAILABLE, IS INCREASING. USED EQUIPMENT SHOULD MEET THE SAME STANDARDS AS NEW AS FAR AS MFR SPECS ETC. ALSO, BACKGROUND DATA SHOULD BE AVAILABLE IE: PREVENTATIVE MAINTENANCE OR REPAIR HISTORIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORCE FX GENERATOR FORCE FX GENERATOR GEI VALLEYLAB, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *