BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM CONSOLE

    MDR report key: 3072538 · Received April 18, 2013

    Report

    Report Number
    1045834-2013-02011
    Event Type
    Malfunction
    Date Received
    April 18, 2013
    Date of Event
    May 8, 2012
    Report Date
    June 1, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND COMPLAINT OF "NOISE" WAS NOT CONFIRMED. THE DEVICE MET MFG SPECS. NO PROBLEM FOUND. IF ADD'L INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE SURGEON COMMENTED ON LOW HUMMING NOISE DURING USE. THE EVENT OCCURRED DURING LUMBAR LAMINECTOMY. THERE WAS NO REPORT OF INJURY OR DEATH. THERE IS NO ADD'L INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167926 SYSTEM CONSOLE HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1