Model AEV (Tan, Commercial) 799-AEV1-01Recalls & reported problems
Zoll Medical Corporation · Ventilator · Class 2
All models of Model AEV (Tan, Commercial) (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Zoll AEV ventilator has 87 reports in the FDA database, with no deaths and no injuries recorded. Many reports describe error messages shown during biomedical or functional testing, such as calibration and self-check failures, and many note that 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
- 87
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 87 adverse event reports that list this exact device (DI 00847946020651), received between Mar 18, 2017 and Aug 3, 2021 — classified as 87 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (39 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
- Device Displays Incorrect Message39
- Failure of Device to Self-Test7
- Improper Alarm7
- Appropriate Device Problem Term/Code Not Available6
- Failure to Power Up4
- Calibration Problem3
- Device Operational Issue3
- Loss of Power3
Patient problems
- No Patient Involvement53
- No Information28
- No Consequences Or Impact To Patient4
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 25 most recent of 87 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 3, 2021Calibration 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 Clinical Signs, Symptoms or Conditions
MAUDE report 12267128 ↗MalfunctionApr 22, 2021Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED AN "OFF SET SELF CHECK FAILURE - 1176" 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 11712029 ↗MalfunctionMay 20, 2020Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED AN UNKNOWN ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 10074955 ↗MalfunctionApr 6, 2020Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED AN "OFF SET SELF CHECK FAILURE - 1174" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9930306 ↗MalfunctionDec 26, 2019Calibration 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 9521397 ↗MalfunctionDec 24, 2019Improper Flow or Infusion; Improper Flow or Infusion
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKOWN), THE DEVICE DISPLAYED AN UNKNOWN "O2 VALVE" ALARM. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Information
MAUDE report 9516395 ↗MalfunctionDec 24, 2019Calibration Problem; Calibration Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL 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 9516389 ↗MalfunctionNov 18, 2019Use of Device Problem; Failure of Device to Self-Test; Use of Device Problem; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED "OFF SET SELF CHECK FAILURE - 1174" AND "AIRWAY PRESSURE SENSING FAILURE - 1052" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9338032 ↗MalfunctionSep 19, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE FAILED THE BREATH PERFORMANCE TEST. THAT IS ALL THE INFORMATION AVAILABLE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 9089022 ↗MalfunctionMay 14, 2019Mechanical Problem; Mechanical Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE HAD AN UNKNOWN COMPRESSOR FAILURE. THIS IS ALL THE INFORMATION AVAILABLE. COMPLAINANT INDICATED THAT THE CLINICIAN MANUALLY BAGGED THE PATIENT TO CONTINUE TREATMENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Information
MAUDE report 8607633 ↗MalfunctionMay 13, 2019Leak/Splash; Leak/Splash
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE'S OXYGEN COULD BE HEARD LEAKING INTERNALLY. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 8605766 ↗MalfunctionApr 2, 2019Failure to Power Up; Failure 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 Patient Involvement
MAUDE report 8475306 ↗MalfunctionMar 29, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE ALARMED. THIS IS ALL THE INFORMATION AVAILABLE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Information
MAUDE report 8464420 ↗MalfunctionFeb 14, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
COMPLAINANT ALLEGED THAT THE DEVICE DOES NOT FUNCTION CORRECTLY. THIS IS ALL THE INFORMATION AVAILABLE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 8340862 ↗MalfunctionJan 25, 2019Mechanical Problem; Mechanical Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "COMPRESSOR FAILURE - 1001" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 8278565 ↗MalfunctionJan 18, 2019Use of Device Problem; Use of Device Problem
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: No Information
MAUDE report 8260883 ↗MalfunctionDec 18, 2018Mechanical Problem; Mechanical Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "COMPRESSOR FAILURE - 1001" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 8174619 ↗MalfunctionDec 6, 2018Use of Device Problem; Use of Device Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "FIRMWARE UPDATE NEEDED" MESSAGE. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Information
MAUDE report 8136925 ↗MalfunctionNov 30, 2018Failure to Calibrate; Failure to Calibrate
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "RUNTIME CALIBRATION FAILURE-1051" 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 Consequences Or Impact To Patient
MAUDE report 8120321 ↗MalfunctionNov 30, 2018Failure 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 AN "POWER ON SELF TEST FAILURE - 1084" ERROR MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN BAG MASK VENTILATED TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THERE WAS NO ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION. PLEASE REFERENCE MEDWATCH REPORT 1220908-2018-03482 FOR A SIMILAR EVENT REPORTED FROM THE FIRST DEVICE USED ON THE SAME PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8119226 ↗MalfunctionNov 5, 2018Failure to Run on Battery; Failure of Device to Self-Test; Failure to Run on Battery; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE WOULD NOT POWER UP WITH BATTERY. ONCE POWERED ON WITH AC POWER, THE DEVICE DISPLAYED AN "OFF SET SELF CHECK FAILURE - 1172" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 8039215 ↗MalfunctionOct 31, 2018Failure of Device to Self-Test; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "1176 - SELF CHECK FAILED" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 8024503 ↗MalfunctionSep 26, 2018Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE WOULD INTERMITTENTLY NOT POWER-UP. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7910772 ↗MalfunctionSep 24, 2018Improper Flow or Infusion; Improper Flow or Infusion
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE FAILED THE MANIFOLD LEAK TEST. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Patient Involvement
MAUDE report 7903408 ↗MalfunctionSep 13, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "RUNTIME CALIBRATION FAILURE" MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN MANUALLY VENTILATED AND INTUBATED THE PATIENT TO CONTINUE TREATMENT. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Information
MAUDE report 7874636 ↗
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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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