Model AEV (Tan, Commercial)Recalls & reported problems across all models
Zoll Medical Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 261
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of Model AEV (Tan, Commercial) by Zoll Medical Corporation in the FDA's device registry (GUDID). Together they are named in 261 adverse event reports in the FDA's MAUDE database, received between Mar 18, 2017 and Aug 31, 2026 — classified as 1 death, 260 malfunctions.
The most frequently reported specific device problem is “Failure of Device to Self-Test” (42 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Model AEV (Tan, Commercial) problems
Device problems
- Failure of Device to Self-Test42
- Mechanical Problem42
- Device Displays Incorrect Message39
- Calibration Problem29
- Failure to Power Up27
- No Display/Image21
- Use of Device Problem20
- Communication or Transmission Problem18
Patient problems
- No Patient Involvement104
- No Clinical Signs, Symptoms or Conditions80
- No Information41
- No Consequences Or Impact To Patient20
- Insufficient Information14
- Administration Site Reaction1
- Death1
Model AEV (Tan, Commercial) models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Model AEV (Tan, Commercial) 799-AEV1-00-01VENTILATOR, CONTINUOUS, FACILITY USE1 death174 reports
- Model AEV (Tan, Commercial) 799-AEV1-01VENTILATOR, CONTINUOUS, FACILITY USE87 reports
Recent Model AEV (Tan, Commercial) adverse event reports
The 15 most recent reports across all models, 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 ↗
Other Zoll Medical Corporation products
- R SERIES94 models · 8,522 reports
- X SERIES163 models · 6,915 reports
- AED PLUS30 models · 1,966 reports · 1 recall
- Z Vent6 models · 1,204 reports · 1 recall
- Model EMV+ Vent, Army, MRI3 models · 964 reports
- E SERIES160 models · 833 reports
- ONESTEP8 models · 586 reports
- M SERIES BIPHASIC59 models · 572 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 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