inforMED
MalfunctionMHX

INTELLIVUE MX800 PATIENT MONITOR

Received Apr 21, 2025 · Event occurred Apr 17, 2025

Report 21872327 · MDR key 21872327

Device

Generic name

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

Catalog number

865240

Product problems

  • Device Alarm System

Patient

NA · Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

THIS MX800 MONITOR IS CONFIGURED WITH OUR STANDARD NICU [NEONATAL INTENSIVE CARE] CONFIGURATION, WHICH INCLUDES RED ALARM FUNCTIONALITY THAT CALLS OUT INTO THE NURSE CALL SYSTEM, WHILE THE YELLOW AND CYAN ALARMS ARE CONFIGURED TO NOT CALL OUT. THIS MONITOR SUDDENLY CHANGED ITS CONFIGURATION FROM THIS FUNCTIONALITY INTO FULL ALARMING INTO THE NURSE CALL SYSTEM FROM ALL ALARMS: RED, YELLOW, AND CYAN. NURSE CALL CABLE AND PORT WERE INITIALLY REPLACED AND VERIFIED TO BE FUNCTIONING CORRECTLY. ISSUE WAS ISOLATED TO MX800. MX800 CONFIGURATION CAN ONLY CHANGE THROUGH SERVICE OR CONFIGURATION MODES AND SHOULD NOT BE ABLE TO REVERT TO ANOTHER CONFIGURATION.