BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION

    MDR report key: 3091798 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-01074
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 12, 2013
    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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE FOUND THREE OUT OF NINE TELEPACKS NEEDED REPLACEMENTS AND TRAINED THE CUSTOMER ON HOW TO EFFECTIVELY TROUBLESHOOT; TRAINED CLINICIANS HOW TO OBTAIN MINDRAY CLINICAL SUPPORT TO AVOID SENDING NON-DEFECTIVE TELEPACKS FOR REPAIR.

    Description of Event or Problem · 1

    CUSTOMER REQUESTED THE COMPANY REPRESENTATIVE TO EVALUATED THE PANORAMA CENTRAL STATION AND AMBULATORY TELEPACKS DUE TO VARIOUS ISSUES, WHICH MAY HAVE AFFECTED IN AMBULATORY TELEMETRY MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187428 PANORAMA CENTRAL STATION CENTRAL MONITORING STATION MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1