NIHON KOHDEN
Received Mar 10, 2023 · Event occurred Mar 7, 2023
Report MW5115655 · MDR key 16529211
Device
Generic name
Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Manufacturer
Nihon Kohden America, Inc.Model number
CNS-6801AProduct problems
- Computer Software Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
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.