BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION WITH TELEPACK

    MDR report key: 3853708 · Received April 16, 2014

    Report

    Report Number
    2221819-2014-00129
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 10, 2014
    Report Date
    March 17, 2014
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    031760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE EVALUATED THE SYSTEM. CUSTOMER PROVIDED WITH LOANER WHILE THE CENTRAL STATION IS BEING RETURNED TO THE COMPANY'S NATIONAL REPAIR CENTER FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234050 PANORAMA CENTRAL STATION WITH TELEPACK CENTRAL STATION MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1