BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION/ TELEPACK

    MDR report key: 3091322 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00168
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    November 30, 2012
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    031760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS RESOLVED (IN TWO OF THREE TELEPACKS) BY REPROGRAMMING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE PANORAMA TELEPACK ALARM RESPONSE FUNCTION. IT IS UNCLEAR, FROM THE CUSTOMER REPORT, IF THIS OCCURRED DURING TELEMETRY MONITORING OR DURING SYSTEM SET UP. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187301 PANORAMA CENTRAL STATION/ TELEPACK CENTRAL STATION MONITORING MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1