BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM CONSOLE, SINGLE PORT, W/IRRIGA

    MDR report key: 3060786 · Received April 5, 2013

    Report

    Report Number
    1045834-2013-01309
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Report Date
    November 21, 2011
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND THE REPORTED CONDITION WAS NOT CONFIRMED. THE DRILL WAS RUN WITH THIS CONSOLE AND REACHED A MAXIMUM TEMPERATURE OF 112 F. THE SPECIFICATION IS A MAXIMUM TEMPERATURE OF 120 F. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE WAS "NOT COOLING PROPERLY." THE DEVICE WAS BEING USED IN SURGERY. THERE WAS NO REPORTED PATIENT OR USER INJURIES. THE DATE OF THE EVENT IS UNKNOWN. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139789 SYSTEM CONSOLE, SINGLE PORT, W/IRRIGA HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1