BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA

    MDR report key: 2193620 · Received July 14, 2011

    Report

    Report Number
    2221819-2011-00006
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    May 13, 2011
    Report Date
    July 30, 2011
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE REPLACED THE POWER SUPPLY IN THE WIRELESS TRANSCEIVER. THE SYSTEM WAS TESTED TO FACTORY SPECIFICATIONS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE PANORAMA CENTRAL STATION WAS IN USE MONITORING PATIENTS ALONG WITH SPECTRUM MONITORS AND AMBULATORY TELEPACKS, THE WIRELESS TRANSCEIVER STOPPED FUNCTIONING, CAUSING THE CENTRAL STATION TO LOSE CONNECTIVITY TO THE PATIENT DEVICES. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PANORAMA CENTRAL STATION MONITORING NETWORK MHX MINDRAY DS USA, INC. PANORAMA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK