BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 MOTOR

    MDR report key: 2934333 · Received January 11, 2013

    Report

    Report Number
    1045834-2013-00084
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 30, 2012
    Report Date
    December 17, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE WAS "RUNNING HOT" DURING TESTING. THE EVENT WAS NOT RELATED TO SURGERY. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19137 EMAX 2 MOTOR HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1