Z Vent 799-EMBP-05-01Recalls & reported problems

Zoll Medical Corporation · MAIN ASSEMBLY, VENTILATOR, COMMERCIAL, ZVENT, MRI ADVANCED · Class 2

All models of Z Vent (6)

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 Z Vent ventilator has 223 adverse event reports, including 222 malfunctions and 1 injury, with no deaths. Many reports describe error messages such as compressor faults and internal communication failures, and some describe the device shutting down unexpectedly during treatment. Most reports record no clinical effect on the patient. There is 1 open recall, begun in April 2024, over manuals missing MRI distance information.

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: 220
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 220 adverse event reports that list this exact device (DI 00847946024185), received between Aug 27, 2019 and Aug 18, 2026 — classified as 1 injury, 219 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (69 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 Problem69
Failure of Device to Self-Test56
Communication or Transmission Problem24
Unexpected Shutdown22
Calibration Problem17
Improper Flow or Infusion16
Use of Device Problem15
Failure to Power Up13

Patient problems

No Clinical Signs, Symptoms or Conditions164
Insufficient Information34
No Patient Involvement9
No Information6
No Consequences Or Impact To Patient5
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Cardiac Arrest1
Hypoxia1

Recent adverse event reports

The 25 most recent of 220 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 18, 2026Noise, Audible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50306912 ↗
MalfunctionJul 1, 2026Communication or Transmission Problem
COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "INTERNAL COMM FAILURE - 1472" AND "INTERNAL COMM FAILURE - 1474" 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 25676730 ↗
MalfunctionMay 18, 2026Communication or Transmission Problem
COMPLAINANT ALLEGED WHILE ATTEMPTING TO MONITORING A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED "INTERNAL COMM FAILED -1173", "INTERNAL COMM FAILED-1471" AND "INTERNAL COMM FAILED-1475" 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 25201704 ↗
MalfunctionMay 7, 2026Unexpected Shutdown
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THE CLINICIAN BAGGED THE PATIENT MANUALLY WITH OXYGEN 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 25113526 ↗
MalfunctionApr 29, 2026Communication or Transmission Problem; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED "5V SELF CHECK FAILURE - 1172" AND "INTERNAL COMM FAILURE- 1474" ERROR MESSAGES. 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 25034863 ↗
MalfunctionApr 26, 2026Mechanical Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED "COMPRESSOR FAULT-2001," AND "COMPRESSOR FAULT-3001" ERROR MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24993156 ↗
MalfunctionApr 22, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING INCOMING INSPECTION, THE DEVICE DISPLAYED A "SELF-CHECK FAILURE- 1003" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24953893 ↗
MalfunctionApr 21, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED AN "OFF SET SELF CHECK FAILURE - 1003" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24939145 ↗
MalfunctionMar 30, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "5V SELF CHECK FAILURE - 1172" 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 24729615 ↗
MalfunctionMar 26, 2026Communication or Transmission Problem
COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN INTERNAL COMM FAILURE 1475 ERROR MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 24700764 ↗
MalfunctionMar 26, 2026Communication or Transmission Problem
COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "INTERNAL COMM FAILURE - 1471" AND SELF CHECK FAULT "INTERNAL COMM FAILURE" 1475 MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 24700666 ↗
MalfunctionMar 13, 2026Unexpected Shutdown
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 24588612 ↗
MalfunctionMar 6, 2026Unexpected Shutdown
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 24532748 ↗
MalfunctionFeb 27, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED WHILE ATTEMPTING TO MONITOR A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "5V SELF CHECK FAILURE - 1172" 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 24470270 ↗
MalfunctionFeb 17, 2026Mechanical Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE EXPERIENCED A "COMPRESSOR FAILURE-2001" 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 24364490 ↗
MalfunctionFeb 13, 2026Mechanical Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WAS UNABLE TO SWITCH MODES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24338224 ↗
MalfunctionFeb 10, 2026Mechanical Problem; No Apparent Adverse Event
THROUGH ADDITIONAL FOLLOW UPS WITH THE END USER, IT WAS IDENTIFIED THAT THIS IS A DUPLICATE COMPLAINT WHICH WAS ALREADY REPORTED UNDER MANUFACTURER REPORT NUMBER: 1220908-2025-04916. THE INITIAL REPORT WAS SUBMITTED TO THE FDA ON 29DEC2025. THE SUPPLEMENTAL REPORT WAS SUBMITTED TO THE FDA ON 16FEB2026.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 24304015 ↗
MalfunctionFeb 4, 2026Mechanical Problem; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "SELF CHECK - 1003" AND "OFF SET SELF CHECK - 1174" AND A "COMPRESSOR - 1001" FAILURE 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 24261200 ↗
MalfunctionFeb 3, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED AN "OFF SET SELF CHECK FAILURE - 1003" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24246113 ↗
MalfunctionFeb 2, 2026Mechanical Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "COMPRESSOR FAILURE -1001 " ERROR MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 24233755 ↗
MalfunctionJan 20, 2026Mechanical Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "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 24114704 ↗
MalfunctionJan 2, 2026Mechanical Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "COMPRESSOR FAULT-2001 " ERROR MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 23943563 ↗
MalfunctionJan 2, 2026Calibration Problem; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED "RUNTIME CALIBRATION FAILURE - 1051," AND "OFF SET SELF CHECK FAILURE - 1174" ERROR MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23943443 ↗
MalfunctionDec 29, 2025Mechanical Problem; Mechanical Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "COMPRESSOR FAULT-3001 " AND "COMPRESSOR FAULT-2001 " 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 23908803 ↗
MalfunctionDec 29, 2025Mechanical Problem; Use of Device Problem; Improper Flow or Infusion; Mechanical Problem; Use of Device Problem; Improper Flow or Infusion
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A 58-YEAR-OLD FEMALE PATIENT, THE DEVICE DISPLAYED A "COMPRESSOR FAULT-2001 " 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 23906495 ↗

Device details

UDI-DI	`00847946024185`
Brand	Z Vent
Model	799-EMBP-05-01
Company	Zoll Medical Corporation
Product code	DQA · Oximeter
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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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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