BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAX 2 MOTOR

    MDR report key: 3030545 · Received March 27, 2013

    Report

    Report Number
    1045834-2013-01017
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 5, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND THE EVENT WAS NOT DUPLICATED. THE DEVICE WAS TESTED AND PASSED ALL MANUFACTURING SPECIFICATIONS. THE EVENT WAS NOT CONFIRMED. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE WAS "HEATING UP". THIS WAS DISCOVERED PRIOR TO A PROCEDURE. THERE WAS NO DELAY IN SURGERY AS A REPLACEMENT DEVICE WAS AVAILABLE. NO INJURIES OR MEDICAL INTERVENTION WERE REPORTED. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125269 MAX 2 MOTOR HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1