BEUDAMED
    FDA Adverse Event Summary report: N

    HORIZON XL PATIENT MONITOR

    MDR report key: 92807 · Received May 23, 1997

    Report

    Report Number
    MW4001885
    Date Received
    May 23, 1997
    Report Date
    April 23, 1997
    Manufacturer
    MENNEN MEDICAL INC.
    Product Code
    DRT
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT MONITORS IN THE EMERGENCY ROOM HAVE INTERMITTENT LOCK UP PROBLEMS. THE RECORDER STOPS PRINTING, THE SPO2 WAVEFORM DISAPPEARS, THE NIBP READINGS ARE INACCURATE ESPECIALLY FOR ELDERLY OR OBESE PATIENTS AND THERE ARE PROBLEMS REQUIRING A SOFTWARE UPDATE. THESE PROBLEMS HAVE NOT BEEN RESOLVED EVEN WITH NUMEROUS ATTEMPTS IN COOPERATION WITH THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HORIZON XL PATIENT MONITOR CARDIAC MONITORING SYSTEM DRT MENNEN MEDICAL INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *