BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION

    MDR report key: 3091467 · Received April 30, 2013

    Report

    Report Number
    2221819-2013-00984
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    August 23, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    031760
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EVALUATED THE SYSTEM. CORRECTIONS INCLUDED REPLACEMENT OF THE SYSTEM'S DISCLOSURE DRIVE. SYSTEM WAS TESTED TO FACTORY'S SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PANORAMA CENTRAL STATION HAD AN ERROR MESSAGE, WHICH MAY HAVE RESULTED IN LOSS OF TELEMETRY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186695 PANORAMA CENTRAL STATION CENTRAL STATION MONITOR MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1