BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 2915629 · Received January 10, 2013

    Report

    Report Number
    1045834-2013-00068
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 11, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE ¿CORD HAD A HOLE IN IT.¿ THE STERILIZATION DEPARTMENT NOTICED THE HOLE WHEN CLEANING AND STERILIZING THE MOTOR. THE EVENT WAS NOT RELATED TO SURGERY. THERE WERE NO INJURIES REPORTED. THE REPORTER CLARIFIED THAT THE CUT WAS IN THE HOSE NOT THE CORD AS THERE WERE NOT EXPOSED ELECTRICAL WIRES. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14539 EMAX 2 PLUS MOTOR HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1