Essential MRI Patient Monitor (Model 865353)Recalls & reported problems
Philips Ds North America LLC · Essential MRI Patient Vital Signs Monitor for monitoring Pulse Oximetry (SpO2) in the MRI environment. Key Features include: Communicates wirelessly with Invivo. Expression or Precess 2nd-Gen wSpO2 Modules for seamless patient transitions, Touch Screen Display Unrestricted MRI Gauss Rating, Lightweight portable Alarm light All parameters support Adult, Pediatric, infant and Neonatal applications,8-Hour Smart Battery Technology, Environmentally friendly Green, Flexible mounting options. 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
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00884838012585), received between Jan 4, 2019 and Oct 15, 2025 — classified as 5 malfunctions.
The most frequently reported specific device problem is “No Audible Alarm” (4 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.
Reports received per month
Most reported problems
Device problems
- No Audible Alarm4
- Device Alarm System1
- Inaudible or Unclear Audible Prompt/Feedback1
Patient problems
- No Patient Involvement3
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 15, 2025No Audible Alarm; No Audible Alarm
AT BENCH, EVALUATING THE DEVICE FOR ANOTHER UNRELATED ISSUE, IT WAS REPORTED THAT THERE WAS NO SOUND COMING FROM THE UNIT. THE DEVICE WAS NOT IN CLINICAL USE AT TIME OF EVENT, NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23284900 ↗MalfunctionMay 5, 2023No Audible Alarm; No Audible Alarm
DURING EVALUATION AT BENCH REPAIR, IT WAS IDENTIFIED THAT THE DEVICE HAD NO AUDIO. THE DEVICE WAS NOT IN USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16874609 ↗MalfunctionMar 5, 2019No Audible Alarm
THE CUSTOMER REPORTED THAT NO ALARM SOUND WAS COMING FROM THE DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT. THERE WAS NO REPORTED PATIENT IMPACT.
Patient problems: No Patient Involvement
MAUDE report 8392852 ↗MalfunctionJan 14, 2019Inaudible or Unclear Audible Prompt/Feedback
THE CUSTOMER REPORTED THAT THERE IS NO SOUND COMING THROUGH THE DEVICE. THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Patient Involvement
MAUDE report 8245283 ↗MalfunctionJan 4, 2019Device Alarm System; No Audible Alarm
THE DISTRIBUTOR REPORTED THAT THE DEVICE WAS DEFECTIVE ON ARRIVAL AND THAT THE SPEAKER HAS NO FUNCTION AND THERE IS NO ALARM SIGNAL. THE DEVICE WAS NOT IN USE ON A PATIENT.
Patient problems: No Patient Involvement
MAUDE report 8217984 ↗
Other Oximeter devices
- Trilogy Trilogy100 Ventilator, InternationalRespironics, Inc. · Oximeter8 deaths2,493 reports
- Trilogy Trilogy 202 Ventilator, United StatesRespironics, Inc. · Oximeter2 deaths1,594 reports
- HAMILTON-G5 159001Hamilton Medical AG · Oximeter18 deaths1,440 reports
- Trilogy Trilogy100 Ventilator, GermanyRespironics, Inc. · Oximeter696 reports
- Model EMV+ Vent, Army, MRI 799-EMVP-04Zoll Medical Corporation · Oximeter1 death605 reports
- Trilogy Evo, O2, Japan JP2100X16BRespironics, Inc. · Oximeter4 recalls5 deaths342 reports
- Model EMV+ Vent, Army, COMMERCIAL 799-EMVP-01-01Zoll Medical Corporation · Oximeter1 death497 reports
- HAMILTON-G5 159002Hamilton Medical AG · Oximeter3 deaths451 reports
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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