BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3080961 · Received April 24, 2013

    Report

    Report Number
    1045834-2013-02018
    Event Type
    Malfunction
    Date Received
    April 24, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 26, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND THE MOTOR DOES NOT ROTATE/FROZEN. EVIDENCE SUGGESTS THIS WAS DUE TO USAGE/WEAR OVER TIME. THE REPORTED MALFUNCTION WAS CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THE DEVICE "HAD AN AIR LEAK." THE REPORTER STATED THAT AIR WAS NOT REACHING THE MOTOR OF THE DEVICE. THE DEVICE WAS NOT USED IN SURGERY AS THE ALLEGED MALFUNCTION WAS DISCOVERED DURING PRE-TESTING. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178075 XMAX MOTOR ERL THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1