BEUDAMED
    FDA Adverse Event Death Summary report: N

    PANORAMA CENTRAL STATION WITH TELEMETRY

    MDR report key: 5500581 · Received March 15, 2016

    Report

    Report Number
    3007222337-2016-00007
    Event Type
    Death
    Date Received
    March 15, 2016
    Date of Event
    February 9, 2016
    Report Date
    March 15, 2016
    Manufacturer
    SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD
    Product Code
    MHX
    PMA / PMN Number
    K150082
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMPANY REPRESENTATIVE EVALUATED THE SYSTEM AND REPORTS THE SYSTEM DID NOT HAVE AUDIBLE ALARM DUE TO A CABLE THAT WAS NOT COMPLETELY PLUGGED INTO THE DEVICE. THERE WERE NO DEVICE RELATED MALFUNCTION. MINDRAY DS USA, INC. ((B)(4)) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. ((B)(4)). (EXEMPTION #E2015032).

    Description of Event or Problem · 0

    CUSTOMER REPORTED AN ISSUE WITH THE PANORAMA CENTRAL STATION WITH TELEMETRY WHERE A PATIENT EXPIRED AND THERE WERE NO AUDIBLE ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156895 PANORAMA CENTRAL STATION WITH TELEMETRY CENTRAL MONITORING STATION MHX SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Death