BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA TIM

    MDR report key: 2980759 · Received January 29, 2013

    Report

    Report Number
    2221819-2013-00022
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    October 10, 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
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP EVALUATED THE PANORAMA TIM AND VERIFIED THE REPORTED PROBLEM. CORRECTIONS INCLUDED REPLACEMENT OF THE POWER SUPPLY AND ADJUSTMENT OF THE VOLTS POWER OF THE ANTENNA OUTPUTS. THE SYS 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 WIRELESS TRANSCEIVER (TIM) DOES NOT COMMUNICATE WITH THE SERVER AND THERE WAS NO POWER ON THE ANTENNAS, WHICH MAY HAVE RESULTED IN A LOSS OF TELEMETRY MONITORING. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40010 PANORAMA TIM NONE MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1