BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3032932 · Received March 29, 2013

    Report

    Report Number
    1045834-2013-01081
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    September 14, 2011
    Report Date
    September 14, 2011
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. RELIABILITY ENGINEERING EVALUATED THE DEVICE WAS FOUND TO MEET PERFORMANCE REQUIREMENTS. HOWEVER, IT WAS NOTED THAT THE HOSE OF THE DEVICE APPEARED DRY, WHICH MAY INDICATE THAT THE UNIT HAD BEEN OPERATED WITHOUT SUFFICIENT LUBRICATION. 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 WAS "HEATING." THE DEVICE WAS NOT BEING USED DURING A PROCEDURE. NO PATIENT OR USER INJURIES WERE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131183 XMAX MOTOR ERL THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1