BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA

    MDR report key: 2980985 · Received January 29, 2013

    Report

    Report Number
    2221819-2013-00021
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    August 16, 2012
    Report Date
    January 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    011540
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EVALUATED THE SYSTEM. CORRECTIONS INCLUDED REPLACEMENTS OF THE SYSTEM HARD DRIVE AND POWER SUPPLY. THE SYSTEM WAS TESTED TO FACTORY'S SPECIFICATIONS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PANORAMA CENTRAL STATION SHUT DOWN AND HAD A BLANK SCREEN THAT DISPLAYED AN ERROR MESSAGE, WHICH MAY HAVE RESULTED IN A LOSS OF AMBULATORY TELEMETRY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38718 PANORAMA NONE MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1