BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM HAND CONTROLLED XMAX MOTOR

    MDR report key: 2864489 · Received December 6, 2012

    Report

    Report Number
    1045834-2012-00059
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    January 27, 2010
    Report Date
    January 27, 2010
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. THE EVENT WAS CONFIRMED. IT WAS DETERMINED THAT DUE TO A TOLERANCE OVERRUN BETWEEN THE ACTUATOR BUTTON AND MOTOR HANDLE, THE MOTOR WOULD RUN SLIGHTLY WHEN THE HANDLE WAS DEPRESSED. THE ACTUATOR BUTTON WAS ADJUSTED IN THE MOTOR IN ORDER TO CORRECT THE PROBLEM. THE ROOT CAUSE WAS DETERMINED TO BE A LACK OF DESIGN CONTROL SPECIFICALLY DESIGN VERIFICATION AND DESIGN VALIDATION ON THE FUNCTION OF THIS NEW CUSTOM MADE PRODUCT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING "THE DEVICE DOES OT TOTALLY DISARM WHEN IN SAFE MODE WITH THE HANDLE. IT STILL RUNS WHEN THE HANDLE IS PRESSED. TH UNIT WAS BEING USED FOR THE FIRST TIME, NO PATIENT WAS INJURED." THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1