BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM CONSOLE

    MDR report key: 3984190 · Received December 18, 2013

    Report

    Report Number
    1045834-2013-08713
    Event Type
    Malfunction
    Date Received
    December 18, 2013
    Report Date
    August 9, 2011
    Manufacturer
    DEPUY SYNTHES POWER TOOLS
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ENGINEERING EVALUATED THE DEVICE, AND THE REPORTED ERROR MESSAGE COULD NOT BE CONFIRMED OR DUPLICATED. THE DEVICE PASSED ALL TESTS AND NO PROBLEMS WERE OBSERVED. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A REPORT FROM THE USA STATED THAT E6 ERROR MESSAGE OCCURRED DURING A CRANIOTOMY; ERROR MESSAGE DISPLAYED ON THE CONSOLE. THE DEVICE WAS REBOOTED. AFTER A SHORT PERIOD OF DRILLING, THE ERROR MESSAGE OCCURRED, HOWEVER, IS UNK IF USER INJURY OR MEDICAL INTERVENTION OCCURRED. THE OCCURRENCE DATE IS UNK. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663927 SYSTEM CONSOLE HBC DEPUY SYNTHES POWER TOOLS

    Patients

    Seq Age Sex Outcome Treatment
    1