BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 3070116 · Received April 15, 2013

    Report

    Report Number
    1045834-2013-01668
    Event Type
    Malfunction
    Date Received
    April 15, 2013
    Date of Event
    May 11, 2012
    Report Date
    May 15, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND THE REPORTED CONDITION WAS CONFIRMED. THIS DEVICE WAS TESTED AND EXCEEDED THE SPECIFICATION FOR TEMPERATURE. ALSO, IT WAS FOUND TO HAVE UNUSUAL NOISE AND VIBRATION. THIS IS MOST LIKELY DUE TO IMMERSION DURING CLEANING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE WAS "RUNNING HOT". THE DEVICE WAS BEING USED DURING MASTOIDECTOMY PROCEDURE. THERE WAS NO REPORTED PT OR USER INJURIES. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160725 EMAX 2 PLUS MOTOR HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1