BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION WITH TELEMETRY

    MDR report key: 4090053 · Received August 18, 2014

    Report

    Report Number
    2221819-2014-00475
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 4, 2014
    Manufacturer
    MINDRAY DS USA INC.
    Product Code
    MHX
    PMA / PMN Number
    031760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS PROVIDED WITH A LOANER, WHILE THE UNIT IS BEING RETURNED FOR FURTHER EVAL.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496254 PANORAMA CENTRAL STATION WITH TELEMETRY CENTRAL MONITORING STATION MHX MINDRAY DS USA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1