BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA

    MDR report key: 1181054 · Received September 29, 2008

    Report

    Report Number
    2221819-2008-00044
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    August 5, 2008
    Report Date
    August 5, 2008
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HOSPITAL SECURITY REBOOTED THE CENTRAL STATIONS AT THE DIRECTION OF THE HOSPITAL BIOMED. ALL CENTRALS CAME UP, BUT THE TELEMETRY SYSTEM STILL HAD NO ECG SIGNALS. THE BIOMED ARRIVED AT THE SITE, AND AFTER CONSULTING WITH THE DATASCOPE PT MONITORING SERVICE REPRESENTATIVE, REBOOTED THE SERVERS, AND CLEARED THE ERROR LOGS. MONITORING WAS SUCCESSFULLY RESUMED ON THE TELEMETRY SYSTEM.

    Description of Event or Problem · 1

    THE COMPANY SERVICE REPRESENTATIVE RECEIVED A CALL FROM THE CUSTOMER STATING THAT A THUNDERSTORM CAME THROUGH THE TOWN AND THE SYSTEM WENT DOWN, WHILE THE HOSPITAL WAS ON EMERGENCY POWER. THE SYSTEM WAS IN USE WITH BEDSIDE MONITORS, AND AMBULATORY TELEPACKS AT THE TIME OF THE EVENT. 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