Z Vent 799-EGB2-00-01Recalls & reported problems

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

All models of Z Vent (6)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Zoll Z Vent ventilator has 757 reports, with 3 deaths and 1 injury. Many reports describe the unit failing to power up, failing its self-test, shutting down unexpectedly, or showing error messages such as compressor or oxygen supply failures. Many reports say no patient was involved. No recalls name this device.

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: 756
Deaths reported: 3
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 756 adverse event reports that list this exact device (DI 00847946024208), received between May 23, 2019 and Sep 29, 2026 — classified as 3 deaths, 1 injury, 752 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (222 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

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

Most reported problems

Device problems

Mechanical Problem222
Failure to Power Up113
Failure of Device to Self-Test98
Improper Flow or Infusion73
Calibration Problem67
Unexpected Shutdown63
Use of Device Problem62
Communication or Transmission Problem46

Patient problems

No Clinical Signs, Symptoms or Conditions580
Insufficient Information99
No Patient Involvement49
No Consequences Or Impact To Patient17
No Information8
Cardiac Arrest2
Death1
Heart Failure/Congestive Heart Failure1

Recent adverse event reports

The 25 most recent of 756 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 29, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934192 ↗
MalfunctionSep 24, 2026Unexpected Shutdown
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE INAPPROPRIATELY SHUT DOWN. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883005 ↗
MalfunctionSep 8, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50669954 ↗
MalfunctionSep 8, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT DURING BIOMED 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 50669832 ↗
MalfunctionSep 8, 2026Unexpected Shutdown
Patient problems: Insufficient Information
MAUDE report 50669817 ↗
MalfunctionSep 4, 2026No 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 50616348 ↗
MalfunctionAug 27, 2026Infusion or Flow Problem
COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "O2 SUPPLY FAILURE - 1020" 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 50478067 ↗
MalfunctionAug 26, 2026Unexpected Shutdown
COMPLAINANT ALLEGED THAT DURING INCOMING INSPECTION, THE DEVICE INAPPROPRIATELY SHUT DOWN.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50453561 ↗
MalfunctionAug 21, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50379947 ↗
MalfunctionAug 18, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50300304 ↗
MalfunctionAug 18, 2026Failure to Power Up; Calibration Problem; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50300238 ↗
MalfunctionAug 14, 2026Improper Flow or Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50254871 ↗
MalfunctionJul 27, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50024897 ↗
MalfunctionJun 30, 2026Failure 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 25670060 ↗
MalfunctionJun 26, 2026Activation Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DID NOT RESPOND TO THE FRONT PANEL CONTROLS. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25634459 ↗
MalfunctionJun 25, 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 25623449 ↗
MalfunctionJun 8, 2026Communication or Transmission Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO DEFIBRILLATE A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "INTERNAL COMM FAILURE- 1471" 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 25435940 ↗
MalfunctionMay 22, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT DURING BIOMED 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 25257612 ↗
MalfunctionMay 20, 2026Mechanical Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "COMPRESSOR FAILURE -1001 " ERROR 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 25234366 ↗
MalfunctionMay 20, 2026Tidal Volume Fluctuations
COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A " TIDAL VOLUME HIGH - 2072" 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 25230727 ↗
MalfunctionMay 19, 2026Calibration Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "RUNTIME CALIBRATION FAILURE - 1051" 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 25219759 ↗
MalfunctionMay 4, 2026Infusion or Flow Problem
COMPLAINANT ALLEGED WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "02 VALVE FAULT FAILURE - 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 25069178 ↗
MalfunctionApr 29, 2026Mechanical Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "COMPRESSOR FAULT-2001 AND 3001 " ERROR MESSAGES. 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 25026304 ↗
MalfunctionApr 29, 2026Mechanical Problem; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED "COMPRESSOR FAILURE -1001" AND "SELF-CHECK FAILURE- 1003" 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 25026296 ↗
MalfunctionApr 27, 2026Infusion or Flow Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED AN "O2 VALVE FAULT- 3011" ERROR MESSAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24999974 ↗

Device details

UDI-DI	`00847946024208`
Brand	Z Vent
Model	799-EGB2-00-01
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 5, 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.

Other VENTILATOR, CONTINUOUS, FACILITY USE devices

Trilogy Trilogy100 Ventilator, United States
Respironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE
92 deaths8,161 reports
Trilogy Evo Trilogy Evo, USA
Respironics, Inc. · Ventilator, continuous, facility use
6 recalls50 deaths4,393 reports
Trilogy 100 Trilogy 100 W/ Bluetooth, USA
Respironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE
65 deaths4,569 reports
CARESCAPE R860
Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE
1 recall1 death4,346 reports
HAMILTON-C1 161001
Hamilton Medical AG · Ventilator, Continuous, Facility Use
2 recalls12 deaths1,849 reports
Trilogy Trilogy O2 Ventilator Japan
Respironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE
7 deaths1,900 reports
Trilogy Trilogy 202 Ventilator International
Respironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE
11 deaths1,564 reports
HAMILTON-C6 160021
Hamilton Medical AG · Ventilator, Continuous, Facility Use
5 recalls10 deaths1,175 reports

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
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page