BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PANORAMA CENTRAL STATION WITH TELEMETRY

    MDR report key: 4090087 · Received August 18, 2014

    Report

    Report Number
    2221819-2014-00495
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 11, 2014
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    PMA / PMN Number
    031760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPANY REPRESENTATIVE EVALUATED THE SYSTEM. CORRECTIONS INCLUDED CLEANING THE UNITS AND REPLACEMENTS OF THE RIBBON CABLE, INTERFACE PCB. UNITS AND SYSTEM WERE CALIBRATED AND SAFETY TESTED TO FACTORY'S SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ISSUES RELATED THE PANORAMA CENTRAL STATION'S AMBULATORY TELEPACKS, WHICH MAY HAVE AFFECTED TELEMETRY MONITORING. NO PATIENT INJURY WAS REPORTED. AFFECTED SERIAL #S: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496270 PANORAMA CENTRAL STATION WITH TELEMETRY CENTRAL MONITORING STATION MHX MINDRAY DS USA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1