BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA

    MDR report key: 1181053 · Received September 29, 2008

    Report

    Report Number
    2221819-2008-00043
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 25, 2008
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE DETERMINED THAT THE SYSTEM SERVER HAD CRASHED. THIS OCCURRED DURING REINSTALL OF EMERGENCY EQUIPMENT; HOWEVER, IT DOES NOT APPEAR THAT THE ONGOING INSTALLATION ACTIVITY WAS RELATED TO THE SYSTEM GOING DOWN. THE COMPANY REPRESENTATIVE CLEARED THE SERVER ERROR LOGS AND RESET THE SYSTEM. THE SYSTEM WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE PANORAMA CENTRAL STATION WAS IN USE MONITORING PTS ALONG WITH TELEPACKS AND PASSPORT 2 MONITORS AT THE BEDSIDES, THE SYSTEM WENT DOWN. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANORAMA PATIENT MONITORING NETWORK DRT MINDRAY DS USA, INC. PANORAMA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK