BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELECT MOBILE COMBO

    MDR report key: 2973755 · Received January 11, 2008

    Report

    Report Number
    1022819-2007-00004
    Event Type
    Malfunction
    Date Received
    January 11, 2008
    Date of Event
    July 18, 2007
    Report Date
    January 9, 2008
    Manufacturer
    CHATTANOOGA GROUP
    Product Code
    IPF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED TO THE MFR FOR EVALUATION. FINDINGS WERE AN UNUSUAL ARRAY OF COMPONENT FAILURES ON THE PRINTED CIRCUIT BOARD. SOFTWARE INSTALLED TO DETECT AND PREVENT OUTPUT SURGE AND REOCCURRENCE.

    Description of Event or Problem · 1

    WHEN CONFIGURED FOR IFC OR 4P THE PT WOULD COMPLAIN OF SHOCKING. NO INJURY REPORTED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELECT MOBILE COMBO POWER MUSCLE STIMULATOR IPF CHATTANOOGA GROUP 2778

    Patients

    Seq Age Sex Outcome Treatment
    1 Other