BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION WITH TELEMETRY

    MDR report key: 5301643 · Received December 16, 2015

    Report

    Report Number
    3007222337-2015-00280
    Event Type
    Malfunction
    Date Received
    December 16, 2015
    Date of Event
    October 26, 2015
    Report Date
    October 27, 2015
    Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECRONICS CO. LTD.
    Product Code
    MHX
    PMA / PMN Number
    K142601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE EVALUATED THE SYSTEM. CORRECTIONS INCLUDED REPLACEMENT OF THE WIRELESS TRANSCEIVER'S POWER SUPPLY AND CLEARING SYSTEM'S ERROR LOGS. MINDRAY DS USA, INC. ((B)(4)) IS SUBMITTING THIS REPORT ON BEHALF OF SHENZHEN MINDRAY (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ISSUE WITH THE PANORAMA CENTRAL STATION WITH TELEMETRY'S WIRELESS TRANSCEIVER, WHICH MAY HAVE AFFECTED TELEMETRY MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830257 PANORAMA CENTRAL STATION WITH TELEMETRY CENTRAL MONITORING STATION MHX SHENZHEN MINDRAY BIO-MEDICAL ELECRONICS CO. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1