inforMED
MalfunctionMHX

NIHON KOHDEN LIFE SCOPE G7

Received Oct 16, 2025 · Event occurred Oct 9, 2025

Report MW5177493 · MDR key 23315404

Device

Generic name

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

Model number

CU-172R

Product problems

  • Operating System Becomes Nonfunctional

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

A NIHON KOHDEN LIFESCOPE G7 PHYSIOLOGIC MONITOR EXPERIENCED AN UNEXPECTED SCREEN LOCK IN THE OPERATING ROOM ON (B)(6) 2025, WHICH CAN IMPAIR THE CLINICIAN'S ABILITY TO MONITOR PATIENT VITAL SIGNS. THIS HAS OCCURRED MULTIPLE TIMES AT OUR HOSPITAL SINCE OPENING IN (B)(6) 2023. IT OCCURRED AGAIN ON (B)(6) 2025 DURING AN URGENT CESAREAN SECTION. THERE ARE AT LEAST 5 OR 6 OTHER TIMES THIS HAS HAPPENED, AND THERE IS NO APPARENT REMEDY OTHER THAN USING A REMOTE CONTROL TO REBOOT THE MONITOR. WE HAVE A DIFFERENT MODEL (LIFESCOPE G9) MONITORS IN ALL OUR OTHER FACILITIES WITH NO REPORTED ISSUES SINCE 2017. NO PATIENT HAS BEEN INJURED OR SUFFERED AN ADVERSE OUTCOME DUE TO THESE GLITCHES, BUT THERE IS A POTENTIAL FOR ADVERSE OUTCOMES IN PARTICULAR SCENARIOS.