BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3042414 · Received April 3, 2013

    Report

    Report Number
    1045834-2013-01245
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY ANSPACH. RELIABILITY ENGINEERING EVALUATED THE DEVICE, AND THE REPORTED PROBLEM COULD NOT BE CONFIRMED. THE UNIT WAS TESTED AND MET ALL SPECIFICATIONS, AND NO PROBLEMS WERE NOTED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE WAS "OVERHEATING". THE DEVICE WAS BEING USED IN SURGERY. THERE WAS NO REPORTED PATIENT OR USER INJURIES. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136437 EMAX 2 PLUS MOTOR HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1