BEUDAMED
    FDA Adverse Event Summary report: N

    ULTRAVIEW

    MDR report key: 3184092 · Received June 12, 2013

    Report

    Report Number
    3184092
    Date Received
    June 12, 2013
    Date of Event
    May 13, 2013
    Report Date
    June 12, 2013
    Manufacturer
    SPACELABS HEALTHCARE
    Product Code
    DRT
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ABOUT A MONTH AGO, SPACELABS MONITORS ALARMING AT BEDSIDE BUT NOT IN THE CENTRALIZED TELEMETRY ROOM FOR ABNORMAL ECTOPY (IN THIS EVENT PT WITH 27 RUNS OF V-TACH) NO ALARMS IN MONITOR TECH ROOM. ALSO LEADS OFF ALARMS HAVE HIGHER PRIORITY THAN ABNORMAL ECTOPY ALARMS IN THE MONITOR TECH ROOM. ALARM SETTINGS AT BEDSIDE UNITS SET TO "ON" AND IN CENTRALIZED MONITOR ROOM, LL ROOMS' ALARMS FOR ECG WERE SET TO "OFF FACTORY DEFAULT." SAME PROBLEM FIVE DAYS LATER; A PT HAD A RUN OF V TACH WITH 7 ECTOPIC BEATS, CARDIAC MONITOR DID NOT ALARM AT BEDSIDE OR IN THE MONITOR TECH ROOM. NO HARM TO PT.CLINICAL ENG NOTIFIED BOTH TIMES.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?MONITOR CARDIAC PATIENTS.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266956 ULTRAVIEW MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) DRT SPACELABS HEALTHCARE 91369 1189078
    267006 ULTRAVIEW MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) DRT SPACELABS HEALTHCARE 91496 14517
    267007 ULTRAVIEW MONITOR, CARDIAC (INCL. CARDIOTACHOMETER & RATE ALARM) DRT SPACELABS HEALTHCARE 91496 1189135

    Patients

    Seq Age Sex Outcome Treatment
    1 *