BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM CONSOLE, SINGLE PORT, NO IRRIGATION

    MDR report key: 3020852 · Received March 18, 2013

    Report

    Report Number
    1045834-2013-00725
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    July 30, 2012
    Report Date
    July 30, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. RELIABILITY ENGINEERING EVALUATED THE DEVICE, AND THE REPORTED PROBLEM WAS CONFIRMED. IT WAS CONCLUDED THAT THE REPORTED NOISE WAS DUE TO ELECTRICAL COMPONENT FAILURE DUE TO NORMAL WEAR FROM NORMAL USE OVER TIME. 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 THE DEVICE WAS "MAKING NOISE." THE DEVICE WAS BEING USED DURING EAR SURGERY. THERE WERE NO PATIENT OR USER INJURIES REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111786 SYSTEM CONSOLE, SINGLE PORT, NO IRRIGATION HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1