BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION WITH TELEMETRY

    MDR report key: 5081203 · Received September 16, 2015

    Report

    Report Number
    3007222337-2015-00272
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Date of Event
    August 28, 2015
    Report Date
    August 28, 2015
    Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.
    Product Code
    MHX
    PMA / PMN Number
    K142601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE EVALUATED THE SYSTEM. CORRECTIONS INCLUDED REPLACEMENT OF THE SYSTEM'S HARD DRIVE, CLEARING THE SYSTEM'S ERROR LOGS, AND REBOOTING. COMMUNICATION WAS REESTABLISHED. SYSTEM WAS SAFETY TESTED TO FACTORY'S SPECIFICATIONS. (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. ((B)(4)).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE PANORAMA CENTRAL STATION WITH TELEMETRY'S SERVER SHUT DOWN, WHICH MAY HAVE AFFECTED TELEMETRY MONITORING. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613456 PANORAMA CENTRAL STATION WITH TELEMETRY CENTRAL MONITORING STATION MHX SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1