BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION WITH TELEPACK

    MDR report key: 3832066 · Received March 7, 2014

    Report

    Report Number
    2221819-2014-00059
    Event Type
    Malfunction
    Date Received
    March 7, 2014
    Date of Event
    December 22, 2013
    Report Date
    January 2, 2014
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    031760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT REPORTS WERE COLLECTED AND IS CURRENTLY UNDER BEING EVALUATED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE PANORAMA CENTRAL STATION WITH TELEPACK, WHICH MAY HAVE AFFECTED TELEMETRY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138517 PANORAMA CENTRAL STATION WITH TELEPACK CENTRAL MONITORING STATION MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1