Efficia CMS200Recalls & reported problems
Philips Medical Systems Hsg · The Efficia CMS200 Central Monitoring System is a "Software with IT Equipment" solution to provide central viewing of physiologic waves, parameters, and trends from other LAN networked Efficia CM monitors , G series and SureSigns VM4/6/8 monitors (requires sw rev. A.03.93 or later) for up to 64 patients at the same time. It provides for the retrospective review of alarm conditions, physiologic waves and parameters from multiple patients (Up to 240 hours of tabular and graphic trends, ECG waveform, alarm events and full disclosure waveforms). It is built on one Philips supplied HP PC with customized embedded Windows 10 OS, supporting 23" 16:9 high resolution HP displays, 24-port network switch(switch is for selected market), one set of mouse and keyboard(keyboard is for selected market) and one USB licensing dongle. It also can be used with a laserjet printer for printing out reports. The printer can either be Philips supplied or locally sourced. It also has the capability to export HL7 data to EMR/HIS via a second network card. A UPS is not included and recommended to be source locally. · Class 2
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00884838058309), received between Oct 24, 2019 and Sep 29, 2026 — classified as 16 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (8 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- No Audible Alarm8
- Application Program Freezes or Fails to Launch4
- Defective Alarm1
- Device Alarm System1
- No Audible Prompt/Feedback1
- Operating System Becomes Nonfunctional1
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions15
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Defective Alarm
It was reported that the alarm at the monitoring center is not working. The device was not in use on a patient at the time of the event, so there was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931735 ↗MalfunctionOct 17, 2025No Audible Alarm; No Audible Alarm
IT WAS REPORTED THERE WAS NO AUDIO BY SPEAKER. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23327584 ↗MalfunctionAug 19, 2025No Audible Alarm; No Audible Alarm
THE CUSTOMER REPORTED THE EFFICIA CMS200 CENTRAL MONITORING SYSTEM DOES NOT EMIT AUDIBLE SOUND. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT. NO ADVERSE EVENT OR PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22837824 ↗MalfunctionMar 24, 2025No Audible Alarm; No Audible Alarm
IT WAS REPORTED THE NURSE STATION DID NOT ALARM. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21684631 ↗MalfunctionMar 21, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
PHILIPS RECEIVED A COMPLAINT ON AN EFFICIA CMS200 CENTRAL MONITORING SYSTEM INDICATING THAT THE EQUIPMENT LOCKED AND STOPPED WORKING; IT STOPPED MONITORING INTENSIVE CARE UNIT (ICU) BEDS. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21663714 ↗MalfunctionDec 5, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
PHILIPS RECEIVED A COMPLAINT ON AN EFFICIA CMS200 CENTRAL MONITORING SYSTEM INDICATING THAT THE EQUIPMENT LOCKED AND STOPPED WORKING; IT STOPPED MONITORING INTENSIVE CARE UNIT (ICU) BEDS. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20852221 ↗MalfunctionSep 6, 2023No Audible Alarm; No Audible Alarm
PHILIPS RECEIVED A COMPLAINT ON THE EFFICIA CMS200 CENTRAL MONITORING SYSTEM INDICATING A SPEAKER ERROR. THE DEVICE WAS IN USE MONITORING A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17690641 ↗MalfunctionAug 14, 2023Device Alarm System; Device Alarm System
THE CUSTOMER REPORTED THAT THERE WAS NO ALARM ON THE CENTRAL. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17540983 ↗MalfunctionJul 7, 2023No Audible Alarm; No Audible Alarm
THE CUSTOMER REPORTED AN ALARM ISSUE. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17280597 ↗MalfunctionAug 30, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
THE CUSTOMER REPORTED THAT THE SCREEN FREEZING AND COMMUNICATION FAILURE WITH BEDSIDE MONITOR. THE DEVICE WAS REPORTED TO BE IN USE ON A PATIENT, BUT NO ADVERSE EVENT TO PATIENT OR USER WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15321980 ↗MalfunctionAug 30, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
THE CUSTOMER SUBMITTED FEEDBACK VIA SALESFORCE STATING "MACHINE FORMATTING AND INSTA SUPPORT." ADDITIONAL INFORMATION WAS REQUESTED TO CLARIFY THE CUSTOMER'S ISSUE. IT WAS REPORTED THE MONITOR WAS LOCKING AND FREEZING IMAGE. IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE EVENT, NO ADVERSE EVENT OR PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15319289 ↗MalfunctionAug 17, 2022Operating System Becomes Nonfunctional; Operating System Becomes Nonfunctional
IT WAS REPORTED TO PHILIPS THAT SYSTEM HANGING, LIVE DATA NOT COMING. THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF EVENT, THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15240083 ↗MalfunctionFeb 9, 2022No Audible Alarm; No Audible Alarm
IT WAS REPORTED TO PHILIPS THAT ALARM SIGNALS FROM THE CONNECTED MONITORS ARE TRANSMITTED TO THE CONTROL PANEL AND ALSO LOGGED, BUT THERE IS NOT ANY ACOUSTIC "ALAMATION" AT THE CONTROL PANEL. IT WAS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13498763 ↗MalfunctionFeb 8, 2022No Audible Alarm; No Audible Prompt/Feedback; No Audible Alarm; No Audible Prompt/Feedback
IT WAS REPORTED TO PHILIPS THAT THE DEVICE DOES NOT MIRROR IMAGE, AND THERE WAS NO AUDIO ALARM. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13480462 ↗MalfunctionFeb 8, 2022No Audible Alarm; No Audible Alarm
IT WAS REPORTED TO PHILIPS THAT THE DEVICE DOES NOT MIRROR IMAGE, AND THERE WAS NO AUDIO ALARM. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13479671 ↗MalfunctionOct 24, 2019Output Problem
THE CUSTOMER CONTACTED THE CUSTOMER CARE SOLUTION CENTER AND REPORTED A SPEAKER FAILURE WITH THE COMPLAINT DEVICE AND REQUESTED SUPPORT. THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9233708 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.