BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION WITH TELEMETRY

    MDR report key: 4213139 · Received September 8, 2014

    Report

    Report Number
    2221819-2014-00538
    Event Type
    Malfunction
    Date Received
    September 8, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 7, 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

    DOCUMENTATION FROM THE EVENT WAS COLLECTED AND IS CURRENTLY UNDER REVIEW.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THE PANORAMA CENTRAL STATION WITH TELEPACK FAILED TO ALARM FOR AN ARRHYTHMIA EVENT. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551353 PANORAMA CENTRAL STATION WITH TELEMETRY CENTRAL MONITORING STATION MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1