BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3955333 · Received December 13, 2013

    Report

    Report Number
    1045834-2013-13083
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE REPORTED COMPLAINT OF "E6 ERROR ON CONSOLE" HAS BEEN CONFIRMED. DURING SERVICE, AN E6 ERROR WAS FOUND ON THE CONSOLE AND THE PRE-REPAIR TESTS COULD NOT BE RUN. IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE DISPLAYED ERROR E6 DURING SURGERY. NO INJURY OCCURRED. IT IS UNK IF SURGICAL DELAY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654164 EMAX 2 PLUS MOTOR HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1