BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 2974210 · Received February 19, 2013

    Report

    Report Number
    1045834-2013-00247
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    May 1, 2012
    Report Date
    May 2, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 THE USA STATING THE DEVICE "HEATED UP DURING A CRANIOTOMY SURGERY." NO INJURIES WERE REPORTED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72426 XMAX MOTOR ERL THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1