Z Vent 799-AEB1-00-01Recalls & reported problems
Zoll Medical Corporation · MAIN ASSEMBLY, VENTILATOR, COMMERCIAL, ZVENT, BASIC · 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 is a facility ventilator that helps patients breathe. Many of its 188 reports describe error messages during self-tests, the device stopping ventilation, or failing to power up. Several reports say no patient was harmed. There is 1 injury report and 2 death reports. 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
- 193
- Deaths reported
- 2
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 193 adverse event reports that list this exact device (DI 00847946024192), received between Aug 1, 2019 and Sep 30, 2026 — classified as 2 deaths, 2 injuries, 189 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (51 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
- Mechanical Problem51
- Failure of Device to Self-Test29
- Improper Flow or Infusion27
- Failure to Power Up24
- Calibration Problem18
- Communication or Transmission Problem17
- No Display/Image16
- Infusion or Flow Problem10
Patient problems
- No Clinical Signs, Symptoms or Conditions150
- Insufficient Information25
- No Patient Involvement12
- No Consequences Or Impact To Patient3
- Necrosis2
- Brain Injury1
- Inadequate Osseointegration1
Recent adverse event reports
The 25 most recent of 193 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Infusion or Flow Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED AN "O2 SUPPLY FAILURE- 1020" ERROR MESSAGE.COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947438 ↗MalfunctionSep 28, 2026Improper Flow or Infusion
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKOWN), THE DEVICE DISPLAYED LOW SUPPLY O2 SUPPLY ERROR 1020.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 50918872 ↗MalfunctionSep 28, 2026Unexpected Shutdown
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUT DOWN.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 50915917 ↗InjurySep 28, 2026Improper Flow or Infusion; Insufficient Device Problem Information
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKOWN), THE DEVICE STOPPED VENTILATING AND DISPLAYED AN UNRECOGNIZED "SHORT IN SYSTEM" ERROR MESSAGE.THE PATIENT RAPIDLY DESATURATE TO 89%. POWER CYCLING RESTORED AIRFLOW, AND BIPAP RESUMED AT 100% FIO2 WITHOUT FURTHER ISSUE.
Patient problems: Insufficient Information
MAUDE report 50913688 ↗MalfunctionSep 24, 2026Mechanical Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "COMPRESSOR SELF CHECK 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 50882913 ↗MalfunctionAug 19, 2026Failure of Device to Self-Test
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50323633 ↗MalfunctionJun 15, 2026Infusion or Flow Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED AN "02 VALVE FAULT - 2011" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25501498 ↗MalfunctionMay 4, 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 25073270 ↗MalfunctionApr 23, 2026Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED AN "OFF SET SELF CHECK FAILURE - 1003" 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 24965315 ↗MalfunctionApr 10, 2026Improper Flow or Infusion
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE STOPPED VENTILATING. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24845053 ↗MalfunctionApr 3, 2026No Display/Image; Failure to Power Up; Unexpected Shutdown
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE INAPPROPRIATELY SHUT DOWN AND THE DEVICE POWERED ON WITHOUT DISPLAY. 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 24781196 ↗MalfunctionMar 30, 2026Gas Output Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED AN "FRESH GAS INTAKE FAILURE -1030" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24727404 ↗MalfunctionMar 30, 2026Improper Flow or Infusion
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), 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 24727320 ↗MalfunctionMar 30, 2026Improper Flow or Infusion
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), 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 24727208 ↗MalfunctionMar 3, 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 24498515 ↗MalfunctionFeb 17, 2026Mechanical Problem; Unexpected Shutdown
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAY A "COMPRESSOR FAILURE- 1001" AND 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 24363253 ↗MalfunctionFeb 17, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24363200 ↗MalfunctionFeb 13, 2026No Display/Image
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE POWERED ON WITHOUT DISPLAY. 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 24338258 ↗MalfunctionFeb 12, 2026Improper Flow or Infusion
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), 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 24321485 ↗MalfunctionFeb 10, 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 24306559 ↗MalfunctionFeb 4, 2026Mechanical Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE STOPPED FUNCTIONING AND DISPLAYED A "COMPRESSOR FAILURE-1001" 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 24259284 ↗MalfunctionJan 26, 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 24185038 ↗MalfunctionJan 15, 2026Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD NOT POWER UP. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24081452 ↗MalfunctionJan 12, 2026Mechanical Problem; Failure to Power Up; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE STOPPED VENTILATING. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24036428 ↗MalfunctionDec 23, 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 23878529 ↗
Other VENTILATOR, CONTINUOUS, FACILITY USE devices
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USARespironics, Inc. · Ventilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USARespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 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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