Expression MR400 MRI Patient Monitoring System (Model MR400) Expression MR400 MRI Patient Monitor SysRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00884838039131), received between Jan 30, 2019 and Sep 28, 2026 — classified as 2 deaths, 7 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Incorrect Measurement” (5 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Unexpected Therapeutic Results; Adverse Event Without Identified Device or Use Problem

  Patient underwent MRI scan with use of Phillips Expression MR400 MRI Patient Monitoring System. After the MRI, he was noted to have a left chest wall burn. Plastic Surgery noted a full thickness chest wall burn that later required surgical debridement and split thickness skin grafting. Manufacturer response for MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS), Expression MR400 MRI Patient Monitoring System (Model MR400) (per site reporter).Provided with IFU changes from "[redacted]"-last year not shared with "[redacted]"-our hospital when published.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 50914635 ↗
• MalfunctionSep 25, 2026Incorrect Measurement

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50902403 ↗
• MalfunctionSep 25, 2026Incorrect Measurement

  Philips received a complaint on the Expression Patient Monitor (MR400) indicating that the Invasive blood pressure(IBP) is inaccurate. The device was not use on a patient at time of event, there was no adverse event reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899390 ↗
• DeathSep 23, 2026No Device Output

  It was reported that while monitoring a sedated patient, the clinical staff noticed a "CO2 hardware error" message. Then, the patient was unable to be monitored and staffed noticed that the patient was non-responsive. The patient died, as attempts to revive the patient by the clinical staff were unsuccessful. No other clinical information or medical intervention was reported; therefore, good faith efforts are being performed.

  Patient problems: Insufficient Information

  MAUDE report 50866242 ↗
• MalfunctionSep 1, 2026Imprecise or Erratic Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50547375 ↗
• MalfunctionNov 25, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED CO2 NOT READING ACCURATELY. PATIENT INVOLVEMENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23644635 ↗
• MalfunctionNov 21, 2025Imprecise or Erratic Results; Imprecise or Erratic Results

  PHILIPS RECEIVED A COMPLAINT ON THE EXPRESSION PATIENT MONITOR (MR400) INDICATING THEY ARE UNABLE TO GET A GOOD SP02 SIGNAL FROM PATIENT. 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 23623788 ↗
• MalfunctionNov 19, 2025Low Readings; Low Readings

  IT WAS REPORTED THE CO2 NUMBERS ARE DRIFTING LOW OUTSIDE OF SERVICE MANUAL SPECS. OVER MINUS 4 FROM 38. 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 23593811 ↗
• MalfunctionNov 4, 2025Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED THAT THE DEVICE FROZE AND SUDDENLY SHUT DOWN. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465125 ↗
• MalfunctionApr 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  PHILIPS RECEIVED A COMPLAINT ON AN EXPRESSION PATIENT MONITOR (MR400) INDICATING THAT THE EQUIPMENT DISPLAYS NON-COMPLIANT OXIMETRY READINGS. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED TO CLARIFY HOW THE READINGS WERE NON-COMPLIANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885424 ↗
• InjuryDec 13, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING AN MRI SCAN OF A NEONATE, THERE WERE MULTIPLE INSTANCES OF SIGNAL INTERFERENCE AND INCORRECT VITAL SIGN READINGS. THIS ISSUE RESULTED IN THE NURSES INITIATING CHEST COMPRESSIONS TO FOLLOW SAFETY PROTOCOL. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF THE EVENT. THERE WAS A REPORT OF PATIENT OR USER HARM.

  Patient problems: Insufficient Information

  MAUDE report 18318808 ↗
• MalfunctionSep 5, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT THE DEVICE SHOWS A VALUE ABOVE THE EXPECTED VALUE FOR SPO2. 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 17684150 ↗
• InjuryFeb 1, 2023Unable to Obtain Readings; Output Problem; Unable to Obtain Readings

  PHILIPS RECEIVED A COMPLAINT ON THE EXPRESSION PATIENT MONITOR (MR400) INDICATING THAT THEY EXPERIENCED PROBLEMS WHILE MONITORING A PATIENTS SPO2. THE CUSTOMER REPORTS THAT A PATIENT WAS EXPERIENCING SHORTNESS OF BREATH AND DID NOT HAVE A PULSE. THE CUSTOMER STATES THAT THE PATIENT RECEIVED CARDIOPULMONARY RESUSCITATION AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. WHILE PROVIDING CARE TO THE PATIENT THE SPO2 MONITORING SHOWED NO VALUE ON SEVERAL OCCASIONS, AFTER REPOSITIONING THE SPO2 FINGER SENSOR THE VALUES DISPLAYED WERE FLUCTUATING YET ACCURATE. THE DATE OF THE THIS INCIDENT WAS DOCUMENTED AS 25-JAN-2023. THE CUSTOMER REPORTS THAT THE PATIENT EXPIRED OF AN UNKNOWN CAUSE.

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16276538 ↗
• DeathJun 24, 2022Incorrect Measurement; Incorrect Measurement

  THE CUSTOMER REPORTED THAT THEY HAD CONCERNS ABOUT SPO2 NOT FUNCTIONING PROPERLY DURING A PATIENT EXAMINATION. ACCORDING TO THE CUSTOMER, THE SPO2 READINGS WERE IN THE 80'S WHEN MONITORING OF THE PATIENT BEGAN BEFORE THE EXAMINATION. INTERFERENCE WAS REPORTEDLY NOTED ON THE SPO2 READING AND IT WAS REPORTED THAT THE TECHNOLOGISTS WERE UNSURE IF THE READINGS WERE RELIABLE. THE TECHNOLOGISTS CONTINUED WITH THE EXAMINATION AND THE SPO2 READINGS IN THE 80¿S. THE CUSTOMER CLAIMED THAT THE NURSE ENTERED THE MAGNET ROOM TO GIVE CONTRAST TO THE PATIENT AND THE PATIENT WAS BLUE. A CODE WAS CALLED, BUT THE PATIENT EXPIRED. THE CUSTOMER REQUESTED ONSITE ASSISTANCE TO CHECK DEVICE FUNCTIONALITY AND TO PROVIDE RE-EDUCATION TO THE NURSES AND STAFF USING THE DEVICE. THE CUSTOMER CLAIMED THAT THEY WERE UNSURE IF THE PATIENT¿S DEATH WAS DEVICE-RELATED, BUT THE DEVICE WAS ON THE PATIENT AT THE TIME THE CODE HAD TO BE CALLED.

  Patient problems: Insufficient Information

  MAUDE report 14803530 ↗
• MalfunctionFeb 8, 2022Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT THE ALARM HARDWARE HAD FAILED. 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 13482985 ↗
• InjuryFeb 2, 2022Component or Accessory Incompatibility; Adverse Event Without Identified Device or Use Problem; Component or Accessory Incompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE INVASIVE BLOOD PRESSURE LINE IN WHICH THE PATIENT WAS BURNED WHILE USING THE EQUIPMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED IN ORDER TO DETERMINE THE EXTENT OF THE PATIENT'S BURNS AND IF THE ALLEGED BURNS REQUIRED INTERVENTION TO PREVENT SERIOUS INJURY. THE COMPLAINT DEVICE WAS IN USE AT THE TIME OF THE ALLEGED EVENT. THE PATIENT ALLEGEDLY CAME INTO CONTACT WITH THE DEVICE AND WAS BURNED IN THE PROCESS.

  Patient problems: Burn(s)

  MAUDE report 13423994 ↗
• InjuryAug 10, 2021Component or Accessory Incompatibility; Component or Accessory Incompatibility

  IT WAS REPORTED THAT ON JULY 30, 2021, A REPRESENTATIVE FROM KETTERING MEDICAL CENTER CONTACTED PHILIPS AND REQUESTED INFORMATION ON THE INGREDIENTS OF THE ADHESIVE FOR THE EKG ELECTRODE PADS. IT WAS REPORTED THAT ¿DURING MRI, PT THAT PADS WERE USED ON, DEVELOPED AN ALLERGIC REACTION ON SITE TO ADHESIVE (BLISTERING AND REDNESS). PT WAS NOT WEARING ANY LOTION OR FRAGRANCE AT THE TIME.¿ AS THE EVENT WAS REPORTABLE TO A REGULATORY AUTHORITY, AN INVESTIGATION WAS REQUIRED. ADDITIONAL INFORMATION WAS LATER PROVIDED BY KETTERING MEDICAL CENTER, WHICH ASSERTED THAT THE PATIENT COMPLAINED ABOUT ¿HAVING A HARD TIME SWALLOWING, CHEST PAIN¿ AND FEELING ¿SLIGHTLY OUT OF BREATH¿ DURING THE MRI PROCEDURE. THE PATIENT WAS CONCERNED ABOUT HAVING AN ANAPHYLACTIC REACTION AND PRESENTED TO THE EMERGENCY DEPARTMENT FOLLOWING THE COMPLETION OF THE MRI PROCEDURE. SHE WAS DIAGNOSED WITH AN ALLERGIC REACTION AND PRESCRIBED A 4MG MEDROL DOSE PACK TO RESOLVE THE ALLEGED ALLERGIC REACTION.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 12302469 ↗
• MalfunctionAug 3, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  THE CUSTOMER CONTACTED THE CUSTOMER CARE SOLUTION CENTER AND ALLEGED THAT THE COMPLAINT DEVICE MODULE WAS APPARENTLY BURNT AND REQUESTED SUPPORT. THE COMPLAINT DEVICE WAS NOT IN CLINICAL USE AT THE TIME THAT THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268002 ↗
• MalfunctionJul 13, 2021Incorrect Measurement; Incorrect Measurement

  DURING A SURVEY CONDUCTED AS PART OF POST MARKET CLINICAL FOLLOW UP, THE CUSTOMER CLAIMED THAT THERE WAS A DISCREPANCY IN THE DEVICE¿S TEMPERATURE READINGS. 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 12160324 ↗
• MalfunctionSep 24, 2020Defective Component

  THE CUSTOMER REPORTED THAT THE REAR CASTER WAS DEFECTIVE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10580088 ↗
• MalfunctionSep 17, 2020No Audible Alarm

  THE ACCOUNT MANAGER REPORTED THAT THE AUDIO ON HIS DEMONSTRATION MONITOR HAD GONE OUT. AUDIO IN THIS CASE IS CONSIDERED TO MEAN ALARM ANNUNCIATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10546244 ↗
• InjuryJun 1, 2020Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT AN ER DOCTOR USED THE DEVICE DURING A CODE AND CLAIMS THE DEVICE DIDN'T WORK. AT THIS TIME, THERE IS NO INFORMATION AVAILABLE AS TO THE PATIENT OUTCOME OR ADDITIONAL DETAILS ABOUT THE DEVICE'S REPORTED FAILURE TO FUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10104247 ↗
• InjuryJan 30, 2019Device Sensing Problem

  THE HOSPITAL'S BIOMED REPORTED THAT A PATIENT CODED WHILE ON THE MONITOR AND, DURING THE CODE, THE DEVICE WAS DISPLAYING INTERMITTENT SIGNAL LOSS FOR SPO2.

  Patient problems: No Information

  MAUDE report 8290034 ↗