Z Vent 799-EGB2-01-01Recalls & 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 is a portable commercial ventilator used in hospitals and by emergency transport teams. The 33 reports filed between 2019 and 2021 mostly describe self-test failures and error messages during routine biomedical or shift checks, plus mechanical, pressure, and calibration problems, with no patient involved and no reported harm. No deaths or injuries are described, and 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
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00847946026592), received between Dec 31, 2019 and Nov 11, 2021 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Failure of Device to Self-Test” (17 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.
Most reported problems
Device problems
- Failure of Device to Self-Test17
- Mechanical Problem14
- Communication or Transmission Problem5
- Calibration Problem4
- Pressure Problem4
- Use of Device Problem4
- Disconnection2
- Improper Flow or Infusion2
Patient problems
- No Patient Involvement16
- No Clinical Signs, Symptoms or Conditions11
- No Information3
- Insufficient Information2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 11, 2021Mechanical Problem; Communication or Transmission Problem; Failure of Device to Self-Test; Mechanical Problem; Communication or Transmission Problem; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED SELF TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12797016 ↗MalfunctionNov 11, 2021Mechanical Problem; Use of Device Problem; Communication or Transmission Problem; Failure of Device to Self-Test; Mechanical Problem; Use of Device Problem; Communication or Transmission Problem; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED AN UNKNOWN "PNEUMATIC FAILURE" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12796990 ↗MalfunctionNov 11, 2021Mechanical Problem; Communication or Transmission Problem; Failure of Device to Self-Test; Mechanical Problem; Communication or Transmission Problem; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED AN UNKNOWN "SELF CHECK FAILURE" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12796476 ↗MalfunctionSep 14, 2021Improper Flow or Infusion; Pressure Problem; Improper Flow or Infusion; Pressure Problem
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 12467705 ↗MalfunctionJul 28, 2021Disconnection; Pressure Problem; Disconnection; Pressure Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "PATIENT DISCONNECT 2100" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 12240704 ↗MalfunctionJul 27, 2021Disconnection; Use of Device Problem; Disconnection; Use of Device Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DID NOT OPERATE CORRECTLY. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12235029 ↗MalfunctionJul 1, 2021Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "SELF CHECK ERROR - 1003" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12103417 ↗MalfunctionJun 7, 2021Mechanical Problem; Mechanical 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 11952173 ↗MalfunctionApr 30, 2021Mechanical 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 11754815 ↗MalfunctionApr 19, 2021Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, 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 11685677 ↗MalfunctionMar 29, 2021Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, 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 11580871 ↗MalfunctionMar 10, 2021Use of Device Problem; Use of Device Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE FAILED THE PRE-PRESSURE CHECK. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 11457141 ↗MalfunctionMar 10, 2021Improper Flow or Infusion; Improper Flow or Infusion
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE STOPPED VENTILATING. COMPLAINANT INDICATED THAT THE CLINICIAN BAG VENTILATED 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 11456755 ↗MalfunctionDec 31, 2020Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE FAILED SELF TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 11100197 ↗MalfunctionDec 31, 2020Calibration Problem; Pressure Problem; Calibration Problem; Pressure Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A (B)(6)-YEAR-OLD MALE PATIENT, THE DEVICE DISPLAYED "RUNTIME CALIBRATION FAILURE - 1051" AND "AIRWAY PRESSURE SENSING FAILURE 1052" 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 Consequences Or Impact To Patient
MAUDE report 11100196 ↗MalfunctionDec 29, 2020Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "SELF-CHECK FAILURE - 1003" MESSAGE. 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: No Information
MAUDE report 11089370 ↗MalfunctionDec 7, 2020Pressure Problem; Pressure Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED AN "AIRWAY PRESSURE SENSING FAILURE - 1052" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10960539 ↗MalfunctionDec 4, 2020Mechanical Problem; Failure of Device to Self-Test; Mechanical Problem; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED "SELF CHECK FAILURE - 1003" AND "COMPRESSOR FAILURE - 1001" ERROR MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10945359 ↗MalfunctionNov 22, 2020Mechanical Problem; Failure of Device to Self-Test; Mechanical Problem; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED "COMPRESSOR FAILURE -1001" AND "SELF CHECK FAILURE -1003" MESSAGES. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10881649 ↗MalfunctionNov 16, 2020Mechanical Problem; Calibration Problem; Mechanical Problem; Calibration Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO READY THE DEVICE FOR PATIENT USE (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED "RUNTIME CALIBRATION FAILURE - 1051" AND "COMPRESSOR FAILURE - 1001" ERROR MESSAGES. 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: No Information
MAUDE report 10843773 ↗MalfunctionNov 16, 2020Mechanical Problem; Calibration Problem; Failure of Device to Self-Test; Mechanical Problem; Calibration Problem; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO READY THE DEVICE FOR PATIENT USE (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "SELF CHECK FAILURE - 1003" ERROR MESSAGE. 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: No Information
MAUDE report 10843711 ↗MalfunctionSep 22, 2020Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, 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 Patient Involvement
MAUDE report 10567105 ↗MalfunctionSep 10, 2020Use of Device Problem; Use of Device Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "PATIENT DISCONNECT - 2100" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10514918 ↗MalfunctionAug 27, 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 10459929 ↗MalfunctionAug 12, 2020Mechanical Problem; Mechanical Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED AN "INTERNAL COMM FAILURE-1471" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10395966 ↗
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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
- 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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