BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION WITH TELEPACK

    MDR report key: 3264022 · Received July 31, 2013

    Report

    Report Number
    2221819-2013-01589
    Event Type
    Malfunction
    Date Received
    July 31, 2013
    Date of Event
    June 20, 2013
    Report Date
    July 31, 2013
    Manufacturer
    PANORAMA CENTRAL STATION WITH TELEPACK
    Product Code
    MHX
    PMA / PMN Number
    K031760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE EVALUATED THE SYSTEM AND RECONFIGURED THE SETTINGS BETWEEN THE BEDSIDE MONITORS AND CENTRAL STATION. SYSTEM WAS SAFETY TESTED TO FACTORY'S SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTS AN ISSUE WITH THE PANORAMA CENTRAL STATION'S DISPLAY, WHICH MAY HAVE AFFECTED TELEMETRY MONITORING. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357145 PANORAMA CENTRAL STATION WITH TELEPACK CENTRAL MONITORING STATION MHX PANORAMA CENTRAL STATION WITH TELEPACK

    Patients

    Seq Age Sex Outcome Treatment
    1