BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEGEND XT 4CH COMBO PKG

    MDR report key: 2011794 · Received February 21, 2011

    Report

    Report Number
    1022819-2011-00001
    Event Type
    Other
    Date Received
    February 21, 2011
    Report Date
    February 15, 2011
    Product Code
    IPF
    PMA / PMN Number
    K953615
    Removal / Correction Number
    Z-1218/1232-2008
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS UNIT SHOULD HAVE BEEN PART OF THE RECALL BECAUSE THE SOFTWARE VERSION V2.2 LOADED NEEDS TO BE UPDATED TO A HIGHER VERSION TO PREVENT FROM APPLYING HIGHER THAN EXPECTED ENERGY TO PATIENTS. ONLY APPROXIMATELY 50% OF THE RECALLED DEVICES CAME BACK TO (B)(4) FOR REPAIR OR SERVICE WHEN THE RECALL WAS TERMINATED BY THE FDA. THE CUSTOMER HAS BEEN NOTIFIED DURING THE RECALL AND FAILED TO RETURN THE DEVICE FOR SOFTWARE UPGRADE.

    Description of Event or Problem · 1

    USER FACILITY BIOMED CALLED IN REGARDING ELECTROTHERAPY MACHINE E-STIM SHOCKING PEOPLE. BIOMED DOES NOT HAVE PATIENT INFO AND STATES DOCTOR DOES NOT KNOW WHICH PATIENT IT SHOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGEND XT 4CH COMBO PKG ELECTROTHERAPY IPF 2788 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other