BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUNDASH

    MDR report key: 3878044 · Received May 23, 2014

    Report

    Report Number
    2311923-2014-00002
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 22, 2014
    Manufacturer
    JK PRODUCTS & SERVICES
    Product Code
    LEJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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 POWER HARNESS SHORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309053 SUNDASH RADIUS LEJ JK PRODUCTS & SERVICES 252

    Patients

    Seq Age Sex Outcome Treatment
    1