BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 2883160 · Received December 18, 2012

    Report

    Report Number
    1045834-2012-00129
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 27, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBE
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY ANSPACH. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM USA STATING "OVERHEATING." THE DEVICE WAS NOT BEING USED IN SURGERY. THE DEVICE WAS NOT BEING USED IN SURGERY. THE EVENT OCCURRED PRIOR TO PT USE. NO INJURIES WERE REPORTED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1