BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAX MOTOR

    MDR report key: 2980102 · Received February 21, 2013

    Report

    Report Number
    1045834-2013-00298
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 25, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND WAS FOUND TO HAVE A CUT/TEAR APPROXIMATELY 2 FEET FROM THE MUFFLER END OF THE HOSE. EVIDENCE INDICATES THAT THIS WAS DUE TO HANDLING ISSUES AT THE CUSTOMER'S SITE. THE EVENT WAS CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT WAS RECEIVED FROM THE USA STATING THAT THE DEVICE HAD A "HOLE IN THE HOSE". IT WAS UNKNOWN TO THE REPORTER WHETHER OR NO THE DEVICE WAS USED IN SURGERY. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75240 XMAX MOTOR ERL THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1