Expression MR200 MRI Patient Monitor System MR200 MRI Patient Monitoring SystemRecalls & reported problems
Philips Ds North America LLC · Expression MRI Patient Vital Signs Monitor (Model MR200). Wireless ECG, Wireless Pulse Oximetry (SpO2),Non-Invasive Blood Pressure (NIBP), Integrated End-Tidal CO2, Advanced ECG Filters, Trend Arrows, All parameters support Adult, Pediatric, Infant and Neonatal applications,8-Hour Smart Battery Technology, Gauss Detection Alarm. One (1) day on-site Expression system training. One (1) year limited warranty and factory service for hardware · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 2
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884838033764), received between Mar 4, 2020 and Sep 23, 2026 — classified as 2 deaths, 3 malfunctions.
The most frequently reported specific device problem is “Imprecise or Erratic Results” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Imprecise or Erratic Results1
- Loose or Intermittent Connection1
- Wireless Communication Problem1
Patient problems
- Insufficient Information2
- Laceration(s)1
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Imprecise or Erratic Results
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50872148 ↗MalfunctionMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED A LACERATION IN THE PRESSURE AREA OF A RIGHT TOE USING SENSOR. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS AN INJURY REPORTED.
Patient problems: Laceration(s)
MAUDE report 19320876 ↗DeathApr 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER WANT TO HAVE AN INVESTIGATION ON THE DEVICE. THE DEVICE WAS IN USE AT TIME OF EVENT. A PATIENTS DEATH WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 16666285 ↗DeathSep 16, 2022Wireless Communication Problem; Wireless Communication Problem
THE CUSTOMER REPORTED THAT THERE WAS A COMMUNICATION FAILURE BETWEEN THE MR200 AND IP5 MONITOR. PATIENT WAS REPORTED TO HAVE STOPPED BREATHING.
Patient problems: Insufficient Information
MAUDE report 15439767 ↗MalfunctionMar 4, 2020Loose or Intermittent Connection
THE CUSTOMER (B)(6) REPORTED THAT ONE OF THE DEVICE'S CASTERS WILL NOT REMAIN LOCKED. THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Patient Involvement
MAUDE report 9786768 ↗
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- Welch Allyn, Inc. 901060Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls2 reports
- McKesson Cardiology Hemo 14.0Change Healthcare Canada Company · Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)2 recalls2 deaths2 reports
- Change Healthcare Cardiology Hemo 14.2Change Healthcare Canada Company · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2 recalls1 death1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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