BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA

    MDR report key: 1181056 · Received September 29, 2008

    Report

    Report Number
    2221819-2008-00046
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 8, 2008
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    DRT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REPRESENTATIVE DETERMINED THAT THE TIM TRANSCEIVER POWER SUPPLY HAD FAILED. SHE REPLACED THE 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 THREE PANORAMA CENTRAL STATIONS WERE IN USE MONITORING PATIENTS ALONG WITH SPECTRUMS, PASSPORT 2'S, AND AMBULATORY TELEPACKS, THE CENTRAL STATIONS STOPPED COMMUNICATING. NO PATIENT INJURY WAS REPORTED. (B) (4).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK