BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3060791 · Received April 5, 2013

    Report

    Report Number
    1045834-2013-01315
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Report Date
    April 6, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. RELIABILITY ENGINEERING EVALUATED THE DEVICE, AND THE REPORTED PROBLEM WAS CONFIRMED. THE MOTOR EXHIBITED DAMAGE TO THE LOCKING MECHANISM THAT CREATED FRICTION THAT PRODUCED THE REPORTED HEAT. THE DAMAGE TO THE MOTOR'S LOCKING MECHANISM WAS CONSISTENT WITH EITHER IMPROPER ASSEMBLY OR POWER BRAKING. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM (B)(6) STATING THE DEVICE WAS "HEATING." THE DEVICE WAS BEING USED DURING A PROCEDURE. THE DATE OF THE VENT IS UNK. NO PT OR USER INJURIES WERE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141601 XMAX MOTOR ERL THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1