BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEDECAL

    MDR report key: 2023842 · Received March 14, 2011

    Report

    Report Number
    9617251-2011-00001
    Event Type
    Injury
    Date Received
    March 14, 2011
    Date of Event
    November 24, 2011
    Report Date
    March 8, 2011
    Manufacturer
    SEDECAL S.A. ALGETE
    Product Code
    IZZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THIS EVENT IS IMPROPER MAINTENANCE COUPLED WITH USER ERROR.

    Description of Event or Problem · 1

    THIS EVENT INVOLVES A POWERED X-RAY TABLE. THE OPERATOR REPORTEDLY REC'D AN ELECTRIC SHOCK WHILE HE WAS CONNECTING THE POWER SUPPLY CORD TO THE TABLE. THE POWER CORD WAS ALREADY CONNECTED TO THE WALL SOCKET. THE OPERATOR USED THE CORD IN A VISIBLY DAMAGED STATE. THE SYSTEM HAD BEEN IN USE FOR MORE THAN 5 YEARS. THIS EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEDECAL X-RAY TABLE IZZ SEDECAL S.A. ALGETE FLEXI-DT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention