Model AEV (Tan, Commercial) 799-AEV1-00-01Recalls & 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 174 adverse event reports, with 1 death and no injuries. The reports mostly describe error messages during testing, failures to power up, and sensing or calibration faults, with a few describing the unit stopping ventilation during patient care. 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: 174
Deaths reported: 1
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 174 adverse event reports that list this exact device (DI 00847946023461), received between Jun 20, 2018 and Aug 31, 2026 — classified as 1 death, 173 malfunctions.

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

Reports received per month

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

Most reported problems

Device problems

Mechanical Problem39
Failure of Device to Self-Test35
Calibration Problem26
Failure to Power Up23
No Display/Image19
Communication or Transmission Problem18
Use of Device Problem17
Improper Flow or Infusion13

Patient problems

No Clinical Signs, Symptoms or Conditions78
No Patient Involvement51
No Consequences Or Impact To Patient16
Insufficient Information14
No Information13
Administration Site Reaction1
Death1

Recent adverse event reports

The 25 most recent of 174 reports, in the reporter's own words as published by the FDA.

MalfunctionAug 31, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50520038 ↗
MalfunctionJan 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 24226462 ↗
MalfunctionJan 19, 2026Failure to Power Up; Failure of Device to Self-Test; Pressure Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DELAYED POWER ON, DISPLAYED AN "AIRWAY PRESSURE SENSING FAILURE - 1052," AND "OFF SET SELF CHECK FAILURE - 1174" 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 24108727 ↗
MalfunctionDec 10, 2025Mechanical Problem; Mechanical 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 23768462 ↗
MalfunctionOct 15, 2025Mechanical Problem; Use of Device Problem; Calibration Problem; Pressure Problem; Mechanical Problem; Use of Device Problem; Calibration Problem; Pressure Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED COMPRESSOR FAILURE 1001, AIRWAY PRESSURE SENSING FAILURE 1052, AND RUNTIME CALIBRATION FAILURE 1051 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 23285146 ↗
MalfunctionJun 25, 2025Failure to Power Up; Failure 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 22326692 ↗
MalfunctionJun 9, 2025Mechanical Problem; Mechanical Problem
COMPLAINANT ALLEGED THAT WHILE VENTILATING A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED COMPRESSOR FAULT 2001. THE CLINICIAN CONTINUED TO USE THE DEVICE TO TREAT THE PATIENT. COMPLAINANT INDICATED THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22167962 ↗
MalfunctionApr 21, 2025Unable to Obtain Readings; Unable to Obtain Readings
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED AN "INTERNAL COMM FAILURE - 1474" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21872970 ↗
MalfunctionMar 21, 2025Unexpected Shutdown; Unexpected Shutdown
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN) THE DEVICE INAPPROPRIATELY POWERED OFF. COMPLAINANT INDICATED THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 21663350 ↗
MalfunctionMar 21, 2025Unexpected Shutdown; Unexpected Shutdown
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN) THE DEVICE PROMPTED PM DUE THEN POWERED OFF. COMPLAINANT INDICATED THAT THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 21663232 ↗
MalfunctionJan 3, 2025Infusion or Flow Problem; Infusion or Flow Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED "02 VALVE FAULT - 2011" AND "02 VALVE FAULT - 3011" 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 21065809 ↗
MalfunctionOct 29, 2024Improper Flow or Infusion; Reset Problem; Improper Flow or Infusion; Reset Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE STOPPED VENTILATING AND RESTART/REBOOT ITSELF. COMPLAINANT DID NOT INDICATE THAT THERE WAS ANY ADVERSE EFFECT TO THE PATIENT DUE TO THE REPORTED MALFUNCTION.
Patient problems: Insufficient Information
MAUDE report 20556193 ↗
MalfunctionOct 29, 2024Mechanical Problem; Mechanical Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED THE "COMPRESSOR FAILURE - 1001" AND "COMPRESSOR FAILURE 2001" ERROR MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20555997 ↗
MalfunctionOct 7, 2024Communication or Transmission Problem; Communication or Transmission Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED AN "INTERNAL COMM FAILURE- 1471" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20385969 ↗
MalfunctionSep 12, 2024Calibration Problem; Calibration Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A MALE PATIENT IN HIS 60'S, THE DEVICE DISPLAYED A "RUNTIME CALIBRATION FAILURE - 1051" 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 20207029 ↗
MalfunctionAug 26, 2024Failure to Power Up; Failure to Power Up
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE WOULD NOT POWER UP. 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 20066190 ↗
MalfunctionJun 18, 2024Failure to Power Up; Failure 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 19558296 ↗
MalfunctionMay 7, 2024Failure to Power Up; Failure 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 19259628 ↗
MalfunctionMar 26, 2024Calibration 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 Clinical Signs, Symptoms or Conditions
MAUDE report 18980849 ↗
MalfunctionMar 4, 2024Failure 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 18826568 ↗
MalfunctionFeb 26, 2024Calibration Problem; Calibration Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, 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 18778377 ↗
MalfunctionFeb 23, 2024Mechanical Problem; Mechanical Problem
COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED A "COMPRESSOR FAILURE -1001" 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 18766820 ↗
MalfunctionJan 23, 2024No 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 18562971 ↗
MalfunctionJan 9, 2024No 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 18478386 ↗
MalfunctionJan 4, 2024Mechanical Problem; Mechanical Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "COMPRESSOR FAULT- 2001 " MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18448687 ↗

Device details

UDI-DI	`00847946023461`
Brand	Model AEV (Tan, Commercial)
Model	799-AEV1-00-01
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.

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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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