BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XMAM MOTOR

    MDR report key: 2974163 · Received February 19, 2013

    Report

    Report Number
    1045834-2013-00254
    Event Type
    Malfunction
    Date Received
    February 19, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 23, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    ERL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 IN THE HOSE BETWEEN THE PRESSURE RELIEF VALVE AND THE MOTOR. THIS IS DUE TO MISHANDLING AT THE CUSTOMER SITE. THE EVENT 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 "HOLE IN THE HOSE" OF THE DEVICE DISCOVERED DURING TESTING. THE DEVICE WAS NOT BEING USED DURING SURGERY. THERE WERE NO INJURIES OR MEDICAL INTERVENTIONS REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72677 XMAM MOTOR ERL THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1