BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 MOTOR

    MDR report key: 3042878 · Received April 4, 2013

    Report

    Report Number
    1045834-2013-01362
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 11, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND PASSED ALL MANUFACTURING SPECIFICATIONS. THE EVENT COULD NOT BE CONFIRMED. 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 "HEATING UP" DURING TESTING PRIOR TO SURGERY. NO DELAYS OCCURRED. THE EVENT WAS NOT RELATED TO SURGERY. A SPARE DEVICE, A EMAX2, WAS AVAILABLE FOR USE. THERE WERE NO INJURIES REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139324 EMAX 2 MOTOR HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1