BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIHON KOHDEN

    MDR report key: 16529211 · Received March 10, 2023

    Report

    Report Number
    MW5115655
    Event Type
    Malfunction
    Date Received
    March 10, 2023
    Date of Event
    March 7, 2023
    Report Date
    March 8, 2023
    Manufacturer
    NIHON KOHDEN AMERICA, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NIHON KOHDEN PT MONITORING SYSTEM CENTRAL NURSE STATION (CNS) WAS SAVING A PT'S ECG WAVEFORM AND CALIPER MEASUREMENTS TO THE INCORRECT PT'S ECG/ARRHYTHMIA HISTORY. FOR EXAMPLE, PT A IN ROOM (B)(6) HAS THEIR WAVEFORM STRIP CALIPER MEASUREMENTS TAKEN AND SAVED, BUT END UP IN THE ECG HISTORY OF PT B IN ROOM (B)(6) WITHIN THE NK CNS. CONVERSELY, PT B'S MEASUREMENTS END UP IN THE HISTORY FOR PT A. THIS HAS BEEN AN ONGOING BUT INCONSISTENT ISSUE SINCE WE INSTALLED THE SYSTEM ~ 5 YEARS AGO. REPEATED SERVICE REQUESTS AND INVESTIGATIONS BY NIHON KOHDEN HAVE NOT PROVIDED A CAUSE OR SOLUTION TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445597 NIHON KOHDEN MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX NIHON KOHDEN AMERICA, INC. CNS-6801A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other