BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION WITH TELEMETRY

    MDR report key: 4810947 · Received May 29, 2015

    Report

    Report Number
    2221819-2015-00242
    Event Type
    Malfunction
    Date Received
    May 29, 2015
    Date of Event
    April 29, 2015
    Report Date
    April 30, 2015
    Manufacturer
    MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.
    Product Code
    MHX
    PMA / PMN Number
    K12601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR EVALUATION.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348997 PANORAMA CENTRAL STATION WITH TELEMETRY CENTRAL MONITORING STATION. MHX MINDRAY BIO-MEDICAL ELECTRONICS CO. LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1