BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    882.4360

    MDR report key: 2782825 · Received October 3, 2012

    Report

    Report Number
    1045834-2012-00021
    Event Type
    Malfunction
    Date Received
    October 3, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 7, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE INITIAL REPORT. A FOLLOW UP REPORT WILL BE PROVIDED ONCE THE DEVICE HAS BEEN RETURNED AND EVALUATED.

    Description of Event or Problem · 1

    WHEN THE EMAX2 HAND CONTROL IS ENGAGED ONTO THE MOTOR IT BEGINS TO START IMMEDIATELY WITHOUT THE LEVER BEING PRESSED DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 882.4360 EMAX HAND CONTROL HBB THE ANSPACH EFFORT, INC. EMAX HAND CONTROL

    Patients

    Seq Age Sex Outcome Treatment
    1