Model EMV+, Comm, MRI 799-EMVP-05-01Recalls & reported problems

Zoll Medical Corporation · Ventilator · Class 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.

Quick summary

This ZOLL EMV+ ventilator is a continuous facility-use ventilator built for use during MRI. The 65 reports mostly describe the unit failing to power up, powering on with a blank screen, or showing internal communication, self-check and exhalation system error messages during routine testing and shift checks, with no deaths or injuries reported. One open recall, started in April 2024, covers missing MRI safety distance instructions in the operator's guide.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports: 65
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 00847946023430), received between Oct 30, 2018 and Mar 30, 2026 — classified as 65 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (14 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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

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

Mechanical Problem14
Communication or Transmission Problem13
No Display/Image11
Failure of Device to Self-Test9
Improper Flow or Infusion9
Pressure Problem6
Failure to Power Up5
Unexpected Shutdown5

Patient problems

No Clinical Signs, Symptoms or Conditions47
Insufficient Information10
No Patient Involvement6
No Consequences Or Impact To Patient3

Recent adverse event reports

The 25 most recent of 65 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 30, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, 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 24727391 ↗
MalfunctionFeb 23, 2026No Display/Image
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE POWERED ON WITHOUT DISPLAY. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24420088 ↗
MalfunctionFeb 23, 2026Communication or Transmission Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED "INTERNAL COMM FAILURES- 1472 AND 1474" ERROR MESSAGES. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24413460 ↗
MalfunctionJan 26, 2026Obstruction of Flow
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE INTERMITTENTLY DISPLAYED A "EXHALATION SYSTEM FAILURE - 1061" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24179199 ↗
MalfunctionDec 29, 2025No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE POWERED ON WITHOUT DISPLAY. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23908643 ↗
MalfunctionJul 22, 2025No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO VENTILATE A PATIENT (AGE AND GENDER UNKNOWN), THE DEVICE FUNCTIONED FOR THE PATIENT, BUT THE SCREEN WENT BLACK MIDWAY THROUGH THE CALL. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22564053 ↗
MalfunctionJul 9, 2025Communication or Transmission Problem; Communication or Transmission Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED "INTERNAL COMM FAILURE 1474" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22457721 ↗
MalfunctionJan 17, 2025Mechanical Problem; Failure to Power Up; Failure of Device to Self-Test; Mechanical Problem; Failure to Power Up; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD INTERMITTENTLY NOT POWER UP AND DISPLAYED "COMPRESSOR FAULT - 1001" AND "SELF CHECK FAILURE - 1172" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21179789 ↗
MalfunctionDec 3, 2024Improper Flow or Infusion; Improper Flow or Infusion
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO VENTILATE A 47-YEAR-OLD MALE PATIENT, THE DEVICE STOPPED VENTILATING. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20835801 ↗
MalfunctionJun 6, 2024Noise, Audible; Noise, Audible
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, A CLICKING NOISE WAS HEARD FROM THE DEVICE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19478089 ↗
MalfunctionMar 11, 2024Mechanical Problem; Mechanical Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 63-YEAR-OLD MALE PATIENT, THE DEVICE DISPLAYED A "COMPRESSOR FAULT-2001 " MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN BAG VENTILATED TO CONTINUE TREATING THE PATIENT UNTIL THE DEVICE WAS RESTARTED AND THE ERROR WAS CLEARED. THEN THE CLINICIAN CONTINUED TO USE THE ORIGINAL DEVICE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18881634 ↗
MalfunctionMar 7, 2024Communication or Transmission Problem; Improper Flow or Infusion; Communication or Transmission Problem; Improper Flow or Infusion
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE STOPPED VENTILATING AND DISPLAYED AN "INTERNAL COMM FAILURE- 1175" ERROR MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18857100 ↗
MalfunctionFeb 26, 2024Improper Flow or Infusion; Improper Flow or Infusion
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 47-YEAR-OLD MALE PATIENT, THE DEVICE STOPPED VENTILATING. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 18777716 ↗
MalfunctionFeb 1, 2024Mechanical Problem; Communication or Transmission Problem; Mechanical Problem; Communication or Transmission Problem
COMPLAINANT ALLEGED THAT DURING TRAINING BY FACILITY STAFF, THE DEVICE DISPLAYED "COMPRESSOR FAULT- 2001", "INTERNAL COMM FAILURE - 1175, "INTERNAL COMM FAILURE- 1472", AND "INTERNAL COMM FAILURE -1474" ERROR MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18622420 ↗
MalfunctionJan 17, 2024Communication or Transmission Problem; Communication or Transmission Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED "INTERNAL COMM FAILURE - 1173" AND "INTERNAL COMM FAILURE -1473" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18525986 ↗
MalfunctionDec 18, 2023Communication or Transmission Problem; Communication or Transmission Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 32-YEAR-OLD MALE PATIENT, THE DEVICE DISPLAYED AN "INTERNAL COMM FAILURE -1474" MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN POWER CYCLED THE DEVICE AND CONTINUED USE FOR THE REST OF THE FLIGHT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18344745 ↗
MalfunctionNov 18, 2023Calibration Problem; Calibration Problem
COMPLAINANT ALLEGED THAT A ROUTINE SHIFT CHECK BY A CLINICIAN, 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 Clinical Signs, Symptoms or Conditions
MAUDE report 18166834 ↗
MalfunctionSep 1, 2023No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT PRIOR TO PATIENT USE, THE DEVICE POWERED ON WITHOUT DISPLAY. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17673558 ↗
MalfunctionAug 14, 2023Improper Flow or Infusion; Pressure Problem; Improper Flow or Infusion; Pressure Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO VENTILATE A MALE PATIENT (AGE UNKNOWN), THE DEVICE STOPPED VENTILATING AND DISPLAYED "O2 VALVE FAULT-2011" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17541345 ↗
MalfunctionAug 1, 2023Pressure Problem; Pressure Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO VENTILATE A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "AIRWAY PRESSURE SENSING FAILURE - 1052" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17436460 ↗
MalfunctionJul 13, 2023No 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 Clinical Signs, Symptoms or Conditions
MAUDE report 17315801 ↗
MalfunctionJun 12, 2023Mechanical Problem; Unexpected Shutdown; Mechanical Problem; Unexpected Shutdown
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO VENTILATE A 72-YEAR-OLD MALE PATIENT, THE DEVICE DISPLAYED A "COMPRESSOR FAILURE - 1001" ERROR MESSAGE AND INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THE CLINICIAN MANUALLY VENTILATED THE PATIENT TO CONTINUE TREATMENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17110185 ↗
MalfunctionJun 12, 2023Unexpected Shutdown; Unexpected Shutdown
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WOULD NOT POWER UP. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 17109985 ↗
MalfunctionMay 26, 2023Mechanical Problem; Mechanical Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "COMPRESSOR FAILURE - 1001" ERROR MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN OBTAINED ANOTHER DEVICE TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17010488 ↗
MalfunctionMay 19, 2023No Display/Image; Communication or Transmission Problem; Failure of Device to Self-Test; No Display/Image; Communication or Transmission Problem; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE INTERMITTENTLY POWERED UP WITH NO DISPLAY, WHEN THE DISPLAY DID FUNCTION, THE DEVICE DISPLAYED "INTERNAL COMM FAILURE- 1472" AND "INTERNAL COMM FAILURE- 1474" ERROR MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16970104 ↗

Device details

UDI-DI	`00847946023430`
Brand	Model EMV+, Comm, MRI
Model	799-EMVP-05-01
Company	Zoll Medical Corporation
Product code	CBK · Ventilator, continuous, facility use
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Feb 9, 2026

Device type (GMDN): Transport electric ventilator

An electrically-powered device designed to provide automated, alveolar ventilatory support for patients during interhospital or intrahospital transport, and in emergency situations. It is typically a compact, lightweight, rugged device with internal batteries to power it during patient transport. It typically provides mandatory breaths at pre-set intervals (control mode), not allowing the patient to breathe spontaneously; operation in assist/control and/or synchronized intermittent mandatory ventilation (SIMV) modes is available in some types. It usually includes an airway pressure monitor and low and high pressure alarms; it may be used in ambulances, and in field hospitals.

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All Ventilator, continuous, facility use devices →

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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