Model EMV+, Comm, MRI 799-EMVP-05Recalls & reported problems
Zoll Medical Corporation · MAIN ASSY,EMV+ PORTABLE VENTILATOR SYSTEM, VENTILATOR-COMPRESSOR-AIR/OXYGEN MIXER, AC POWER SUPPLY, 6' OXYGEN HOSE, 12VDC CABLE, MRI, VENTILATOR CIRCUITS, SPO2 CABLE, SPO2 SENSOR, PADDED CASE, COMMERCIAL US · Class 2
All models of Model EMV+, Comm, MRI (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00847946020767), received between Aug 7, 2017 and Jul 28, 2023 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (6 reports).
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Apr 30, 2024Class IOpen, Classified
Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Patient Safety Ventilator MRI information omitted from the manuals. Update to the instructions ensures safe distance from the MRI to ensure proper function of the ventilator and reduce the risk of delay in ventilator therapy
Z-2130-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Device Displays Incorrect Message6
- Calibration Problem2
- Device Operational Issue2
- Communication or Transmission Problem1
- Failure of Device to Self-Test1
- Failure to Power Up1
- Mechanical Problem1
- No Display/Image1
Patient problems
- No Patient Involvement7
- No Clinical Signs, Symptoms or Conditions3
- No Information3
- Insufficient Information1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2023Calibration Problem; Failure of Device to Self-Test; Calibration Problem; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED "RUNTIME CALIBRATION FAILURE - 1051" AND "5V SELF CHECK FAILURE - 1172" ERROR MESSAGES. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 17413972 ↗MalfunctionMar 3, 2023Mechanical Problem; Mechanical Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED "COMPRESSOR FAILURE -1001" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16480891 ↗MalfunctionFeb 28, 2023Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16453300 ↗MalfunctionMay 6, 2021Communication or Transmission Problem; Communication or Transmission Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED AN "INTERNAL COMM FAILURE - 1474" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11784836 ↗MalfunctionFeb 4, 2020Calibration Problem; Calibration Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED A "RUNTIME CALIBRATION FAILURE - 1051" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9667318 ↗MalfunctionJan 25, 2019No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE POWERED ON WITHOUT DISPLAY. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 8278610 ↗MalfunctionApr 17, 2018Device Displays Incorrect Message; Device Displays Incorrect Message
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6)YEAR OLD FEMALE PATIENT, THE DEVICE DISPLAYED AN ?OFF SET SELF CHECK FAILURE" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Information
MAUDE report 7437181 ↗MalfunctionMar 23, 2018Device Displays Incorrect Message; Device Displays Incorrect Message
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "AIR INTAKE" MESSAGE. NO FURTHER INFORMATION WAS AVAILABLE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Information
MAUDE report 7365547 ↗MalfunctionMar 19, 2018Device Operational Issue; Device Operational Issue
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING THE DEVICE FAILED COMPRESSOR AND AIRWAY TESTING. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7348528 ↗MalfunctionMar 19, 2018Device Operational Issue; Device Operational Issue
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED COMPRESSOR AND AIRWAY TESTING. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7348515 ↗MalfunctionMar 18, 2018Device Displays Incorrect Message; Device Displays Incorrect Message
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "RUNTIME CALIBRATION FAILURE-1051" MESSAGE COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7347830 ↗MalfunctionNov 13, 2017Device Displays Incorrect Message; Device Displays Incorrect Message
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED AN "O2 COMPRESSOR FAILURE" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7025199 ↗MalfunctionAug 16, 2017Device Displays Incorrect Message; Device Displays Incorrect Message
COMPLAINANT ALLEGED THAT THE DEVICE DISPLAYED A "COMPRESSOR FAILURE" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 6798135 ↗MalfunctionAug 7, 2017Device Displays Incorrect Message; Device Displays Incorrect Message
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6) OLD MALE PATIENT, THE DEVICE DISPLAYED A "COMPRESSOR FAILURE" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Information
MAUDE report 6771767 ↗
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 · each recall links to the FDA recall notice
- 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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