BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNDASH

    MDR report key: 2856210 · Received October 30, 2012

    Report

    Report Number
    2311923-2012-00019
    Event Type
    Malfunction
    Date Received
    October 30, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 30, 2012
    Manufacturer
    JK PRODUCTS & SERVICES, INC.
    Product Code
    LEJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN 806 SUBMITTED TO THE (B)(4) DISTRICT OFFICE OF THE FDA.

    Description of Event or Problem · 1

    WIRING IN A POWER HARNESS SHORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUNDASH RADIUS 252 LEJ JK PRODUCTS & SERVICES, INC. RADIUS 252

    Patients

    Seq Age Sex Outcome Treatment
    1