BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMBAR EXTENSION MACHINE

    MDR report key: 376779 · Received February 6, 2002

    Report

    Report Number
    1051095-2002-00001
    Event Type
    Malfunction
    Date Received
    February 6, 2002
    Manufacturer
    MEDX 96, INC.
    Product Code
    ION
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    USER NOTICED CRACK IN MOVEMENT ARM DUE TO POSSIBLE WELD FAILURE. USER DISCONTINUED USE OF MACHINE BEFORE COMPLETE FAILURE. NO INJURY OCCURED. MOVEMENT ARM HAS BEEN REPLACED MDEX AWAITING RETURN FOR FULL EVAL. WELD FAILURE SUSPECT.

    Description of Event or Problem · 1

    USER NOTICED CRACK IN MOVEMENT ARM DUE TO POSSIBLE WELD FAILURE. USER DISCONTINUED USE OF MACHINE BEFORE COMPLETE FAILURE. NO INJURY OCCURRED. MOVEMENT ARM HAS BEEN REPLACED. MEDX AWAITING RETURN FOR FULL EVAL. WELD FAILURE SUSPECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMBAR EXTENSION MACHINE MEASURING EXERCISE MACHINE ION MEDX 96, INC. MEDX LUMBAR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other