BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 3000205 · Received February 14, 2013

    Report

    Report Number
    1045834-2013-00243
    Event Type
    Malfunction
    Date Received
    February 14, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 18, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND FOUND TO HAVE AN AIR LEAK IN INNER HOSE NEAR SWIVEL. THIS IS MOST LIKELY DUE TO USAGE/WEAR OVER TIME. THE EVENT WAS CONFIRMED. 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 THAT THE DEVICE HAD AN "AIR LEAK" IN THE HOSE. THE REPORTER STATED THAT THE DEFICIENCY WAS DISCOVERED DURING A SURGERY BUT PRIOR TO BEING USED ON THE PATIENT. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65369 XMAX MOTOR ERL THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1