BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMX 2 PLUS MOTOR

    MDR report key: 3042423 · Received April 3, 2013

    Report

    Report Number
    1045834-2013-01256
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    November 30, 2011
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY ANSPACH. RELIABILITY ENGINEERING EVALUATED THE DEVICES, AND THE REPORTED PROBLEM WAS CONFIRMED FOR THE DEVICE, WHICH EXCEEDED TEMPERATURE SPECIFICATIONS DURING TESTING. THE UNIT WAS DETERMINED TO HAVE A DAMAGED HALL SENSOR AND FRONT END BEARING. IT WAS CONCLUDED THAT THE DAMAGE HAD LIKELY BEEN CAUSED BY IMMERSION, WHICH IS INDICATIVE OF IMPROPER CLEANING OF THE EQUIPMENT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE WAS "HEATING UP." THE DEVICE WAS NOT BEING USED IN SURGERY. 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
    136867 EMX 2 PLUS MOTOR HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1