BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICS INFINITY CENTRAL STATION

    MDR report key: 1052863 · Received May 27, 2008

    Report

    Report Number
    1220063-2008-00017
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    April 27, 2008
    Report Date
    May 27, 2008
    Manufacturer
    DRAEGER MEDICAL SYSTEMS, INC. (IT/M)
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MOTHERBOARD OR THE CPU OF THE DEVICE IS BEING RETURNED TO THE MFR. AS SOON AS THE DEVICE IS RECEIVED, INVESTIGATION WILL START AND RESULTS AND CORRECTIVE ACTION WILL BE COMMUNICATED TO FDA.

    Description of Event or Problem · 1

    SEVERAL REBOOTS AT ICS INFINITY CENTRAL STATION. THIS TIME IT APPARENTLY TURNED OFF AND ON BY ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICS INFINITY CENTRAL STATION PATIENT MONITORING DRT DRAEGER MEDICAL SYSTEMS, INC. (IT/M)

    Patients

    Seq Age Sex Outcome Treatment
    1