BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.0 CM SHORT ATTACHMENT

    MDR report key: 3042373 · Received April 3, 2013

    Report

    Report Number
    1045834-2013-01221
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    April 25, 2012
    Report Date
    April 25, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. RELIABILITY ENGINEERING EVALUATED THE DEVICE AND THE REPORTED HEAT WAS NOT CONFIRMED OR DUPLICATED. THE DEVICE MET ALL SPECIFICATIONS, AND NO PROBLEMS WERE FOUND. 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 THAT THE DEVICE WAS "HEATING UP." THE DEVICE WAS BEING USED DURING A COCHLEAR IMPLANT PROCEDURE. NO PATIENT OR USER INJURIES WERE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136924 5.0 CM SHORT ATTACHMENT HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1