BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIHON KOHDEN

    MDR report key: 22861350 · Received August 21, 2025

    Report

    Report Number
    MW5175060
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    July 9, 2025
    Report Date
    August 13, 2025
    Manufacturer
    NIHON KOHDEN AMERICA, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE ISSUE: INCORRECT LOCATION OF PACEMAKER MARKERS ON ECG WAVEFORMS MANUFACTURER: NIHON KOHDEN EQUIPMENT INVOLVED: CNS-6801 CENTRAL NURSES STATION, VERSION 02-05, SERIAL # (B)(6); CNS-2101 CENTRAL NURSES STATION, VERSION 02-04, SERIAL # (B)(6); CU-158R, G5 MAX PATIENT MONITOR; ZM-531PA TELEMETRY TRANSMITTER; ORG-9110A MULTIPLE PATIENT RECEIVER DETAILS: EQUIPMENT WAS INSTALLED IN OUR NEW BUILDING JUNE 2025. PATIENT GO-LIVE (B)(6) 2025. ON (B)(6) 2025 IT WAS DISCOVERED BY PACEMAKER REPRESENTATIVES THAT THE PACEMAKER MARKERS ON THE PATIENT MONITOR ECG WAVEFORMS WERE IN THE WRONG PLACE. A REPRESENTATIVE FROM NIHON KOHDEN WAS ON SITE, OBSERVED THE ISSUE AND REPORTED IT TO TECHNICAL SERVICES FOR INVESTIGATION. THE SERVICE TICKET # IS (B)(4). THIS ISSUE HAPPENS WHEN USING THE HI-Q VIEW FEATURE ON THE G5 PATIENT MONITOR OR THE CENTRAL NURSES STATION. THIS FEATURE ALLOWS THE TELEMETRY TRANSMITTER TO "PAIR" WITH THE G5 PATIENT MONITOR SO BOTH DEVICES CAN BE USED AT THE SAME TIME. WHEN THE HI-Q VIEW FEATURE IS OFF THE PACEMAKER MARKER DISPLAYS IN THE PROPER PLACE ON THE ECG WAVEFORM STAFF HAS BEEN ADVISED TO NOT USE THE HI-Q VIEW FEATURE. PATIENT CODE: 4582. DEVICE CODE: 2616, 3283. REFERENCE REPORT# MW5175061, MW5175062, MW5175063, MW5175064.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182739 NIHON KOHDEN MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX NIHON KOHDEN AMERICA, INC. CNS-6801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other