BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPX-60

    MDR report key: 599229 · Received April 29, 2005

    Report

    Report Number
    1418957-2005-00007
    Event Type
    Malfunction
    Date Received
    April 29, 2005
    Date of Event
    December 2, 2004
    Report Date
    April 28, 2005
    Manufacturer
    FISCHER IMAGING CORP.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE MOVING THE EPX-60 C ARM TO THE MAXIMUM HEIGHT THE ARM FELL TO THE LOWEST MECHANICAL POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPX-60 ELECTROPHYSIOLOGY IMAGING SYSTEM JAA FISCHER IMAGING CORP. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *