Expression MRI Patient Monitoring System (Model 865214)Recalls & reported problems
Philips Ds North America LLC · Expression MRI Patient Vital Signs Monitor, Wireless 2.4 GHz Dual Lead ECG Capable, Wireless 2.4 GHz, Pulse Oximetry (SpO2) Capable, Integrated Non-Invasive Blood Pressure (NIBP), Advanced ECG Filter, Integrated End-Tidal CO2, Active Trend Arrows, 360 Degree Alarm light, Quick Connect Accessories, All parameters support Adult, Pediatric, Infant and Neonatal applications, 8-Hour Smart Battery Technology, One (1) year limited warranty and factory service for hardware, Patient Monitor manufactured by Philips Healthcare and branded for Invivo Corporation, anaffiliate of Philips Healthcare. The Patient Monitor is provided with Invivo's standard 1 year. Warranty,a copy of which is available upon request. Post warranty service may be purchased for the Invivo Patient Monitor at the point of sale. For service after the point-of-sale, please contact. Invivo at 1-877-468-4861 option 1, option 3. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 1
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00884838016064), received between Mar 4, 2019 and Aug 9, 2022 — classified as 1 death, 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Battery Problem” (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.
Most reported problems
Device problems
- Battery Problem1
- Component Incompatible1
- Detachment of Device or Device Component1
- Device Markings/Labelling Problem1
- Failure to Charge1
- Fire1
- High Readings1
- Incorrect Measurement1
Patient problems
- No Patient Involvement4
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information2
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 9, 2022Incorrect Measurement; Wireless Communication Problem; Incorrect Measurement; Wireless Communication Problem
THE CUSTOMER REPORTED TO THE FRONT-LINE AGENT THAT THERE WAS A COMMUNICATION PROBLEM WITH THE DEVICE AND THAT THE VITALS COMING OVER ARE INCORRECT. ADDITIONAL INFORMATION ABOUT THE INCORRECT VITALS WAS REQUESTED FROM THE CUSTOMER MULTIPLE TIMES, BUT NO FURTHER INFORMATION HAS BEEN RECEIVED. THERE WAS NO REPORTED PATIENT OR USER IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15192333 ↗InjuryJan 24, 2022Failure to Charge; Failure to Charge
IT WAS REPORTED VIA MEDWATCH (B)(4) THE INVIVO EXPRESSION MRI SAFE PATIENT MONITOR BASE/CART FAILED WHICH PREVENTED THE MONITOR PORTION OF THE SYSTEM FROM BEING ABLE TO COMMUNICATE WITH THE LEADS PLACED ON THE ICU INPATIENT FOR MONITORING DURING THE EXAM. WITHOUT THE ABILITY TO SAFELY MONITOR THE PATIENT WHILE THEY WERE INSIDE THE MRI UNIT, WE WERE UNABLE TO PERFORM THE PATIENT¿S SCAN. THE INABILITY TO PROVIDE THE REQUESTED MRI IMAGING ON THIS PATIENT POTENTIALLY DELAYED TREATMENT AND TRANSITION TO NEXT LEVEL OF CARE.
Patient problems: Insufficient Information
MAUDE report 13334732 ↗DeathDec 15, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A CRITICAL INCIDENT ON (B)(6) 2021 WHERE THE PATIENT'S BLOOD PRESSURE COULD NOT BE APPROPRIATELY MONITORED DUE TO AN UNSPECIFIED MONITOR FAILURE. THE PATIENT WAS INDICATED BY THE CUSTOMER TO HAVE PASSED AWAY.
Patient problems: Insufficient Information
MAUDE report 13011664 ↗MalfunctionMay 12, 2021Component Incompatible; Component Incompatible
THE CUSTOMER REPORTED THAT THE RIGHT FRONT CASTER FELL OFF THE DEVICE. 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 11810861 ↗MalfunctionApr 13, 2021High Readings; High Readings
THE CUSTOMER REPORTED THAT THE SPO2 READINGS WERE HIGH. 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 11655538 ↗MalfunctionJun 27, 2019Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE DEVICE'S WHEEL FELL OFF AND THE NUT FELL INSIDE THE CASE. THE DEVICE WAS NOT IN CLINICAL USE WHEN THE ISSUE OCCURRED.
Patient problems: No Patient Involvement
MAUDE report 8741065 ↗MalfunctionMay 10, 2019Battery Problem
THE BIOMED REPORTED THAT THE WIRELESS MODULE WAS SENT TO THE SHOP BECAUSE THE BATTERY WAS STUCK IN THE WIRELESS MODULE. THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Patient Involvement
MAUDE report 8598963 ↗MalfunctionMay 9, 2019Device Markings/Labelling Problem
THE DISTRIBUTOR CLAIMED THAT A BATTERY (PART NUMBER 9065; BATT.3.7V,WRLS.PAT.MDLE. ROHS) WAS RECEIVED WITHOUT A LABEL. THE LABEL THAT IS MISSING FROM THE BATTERY CONTAINS NO TEXT AND IS ALL SYMBOLS. THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Patient Involvement
MAUDE report 8596454 ↗MalfunctionMar 4, 2019Fire
THE CUSTOMER REPORTED THAT THE SPO2 MODULE AND BATTERY "CAUGHT FIRE". THE DEVICE WAS NOT IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO REPORT OF ANY ADVERSE EVENT.
Patient problems: No Patient Involvement
MAUDE report 8387305 ↗
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- McKesson Cardiology Hemo 14.0Change Healthcare Canada Company · Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)2 recalls2 deaths2 reports
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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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