BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3102635 · Received May 1, 2013

    Report

    Report Number
    1045834-2013-02067
    Event Type
    Malfunction
    Date Received
    May 1, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND PASSED ALL MANUFACTURING SPECIFICATIONS. THE REPORTED CONDITION 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 THAT THERE WAS A "LEAK IN THE HOSE" OF THE MOTOR DEVICE AND IT WAS UNK IF THE LEAK WAS AIR, OIL OR BOTH. IT WAS UNK TO THE REPORTER WHERE THE EXACT LOCATION OF THE HOLE WAS. IT WAS UNK TO THE REPORTER IF THE MOTOR DEVICE WAS USED IN SURGERY. THE REPORTER CONFIRMED THAT THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190755 XMAX MOTOR ERL THE ANSPACH EFFORT, INC. XMAX_LL

    Patients

    Seq Age Sex Outcome Treatment
    1