BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINDRAY PANORAMA SYSTEM

    MDR report key: 3770884 · Received January 13, 2014

    Report

    Report Number
    3770884
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    December 22, 2013
    Report Date
    December 30, 2013
    Manufacturer
    MINDRAY DS USA, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT HAD BEEN AMBULATED TO THE BATHROOM AND UPON RETURN TO THE BED AT 0705, THE PT BECAME UNRESPONSIVE. CAROTID PULSE CHECKED BY THE STAFF. NO PULSE WAS FELT. CODE WAS CALLED. THE PT WAS SUCCESSFULLY RESUSCITATED AND TRANSFERRED TO THE CRITICAL CARE UNIT. THE PT HAD BEEN IN ATRIAL FIBRILLATION PRIOR TO THIS EVENT. THE PT'S CARDIAC MONITORING SYSTEM FAILED TO RECOGNIZE A BRADYCARDIA RHYTHM OR ASYSTOLE. PT HAD PAUSES OVER SIX (6) SECONDS. SYSTEM BPM (BEATS PER MINUTE) WERE BLANK. NO ALARM SOUNDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31474 MINDRAY PANORAMA SYSTEM TELEMETRY AND BEDSIDE MONITORING SYSTEM MHX MINDRAY DS USA, INC. 0998-00-0708-01

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention