Model Eagle II 799-EGL2-00-01Recalls & reported problems
Zoll Medical Corporation · Ventilator · Class 2
All models of Model Eagle II (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Zoll Medical Model Eagle II ventilator is a portable oxygen/ventilation unit used in emergency and transport care. The 45 reports describe self-test and compressor failure error messages during routine biomedical testing, plus units failing to power on or showing empty-battery and calibration messages. There are45 malfunction reports, with no deaths and no injuries, 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
- 45
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00847946023447), received between Oct 4, 2018 and Nov 26, 2024 — classified as 45 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (18 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 Problem18
- Failure of Device to Self-Test16
- Failure to Power Up6
- Calibration Problem4
- Communication or Transmission Problem3
- Use of Device Problem3
- Grounding Malfunction1
- No Display/Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- No Patient Involvement16
- No Information1
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 26, 2024Mechanical Problem; Failure of Device to Self-Test; Mechanical Problem; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED "COMPRESSOR FAILURE - 1001" AND "SELF CHECK FAILURE - 1003" ERROR MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20785032 ↗MalfunctionAug 22, 2024Use of Device Problem; Use of Device Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED AN "EMPTY BATTERY - 1430" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20044420 ↗MalfunctionAug 1, 2024No Display/Image; No Display/Image
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, 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 19881970 ↗MalfunctionJun 28, 2024Failure 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-1176" ERROR MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19632427 ↗MalfunctionJan 25, 2024Mechanical Problem; Mechanical Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, 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 18578892 ↗MalfunctionJan 4, 2024Mechanical Problem; Mechanical Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED "COMPRESSOR FAULT-2001 " AND " COMPRESSOR FAULT 3001 " MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18443138 ↗MalfunctionNov 6, 2023Mechanical Problem; Calibration Problem; Failure of Device to Self-Test; Mechanical Problem; Calibration Problem; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED "COMPRESSOR FAILURE -1001," "COMPRESSOR FAULT-2001," "SELF CHECK FAILURE -1003," AND "RUNTIME CALIBRATION FAILURE - 1051" ERROR MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18073316 ↗MalfunctionMay 16, 2023Mechanical Problem; Failure of Device to Self-Test; Mechanical Problem; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED "COMPRESSOR FAILURE -1001" AND "SELF CHECK FAILURE -1003" ERROR MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16939809 ↗MalfunctionDec 22, 2022Failure to Power Up; Failure 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 16038087 ↗MalfunctionNov 9, 2022Mechanical Problem; Mechanical Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED "COMPRESSOR FAULT- 2001 " AND "COMPRESSOR FAULT- 3001" ERROR MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15759809 ↗MalfunctionOct 11, 2022Mechanical Problem; Mechanical Problem
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED A "COMPRESSOR FAILURE -1001" MESSAGE. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15580082 ↗MalfunctionJul 20, 2022Failure 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 15068100 ↗MalfunctionMay 26, 2022Failure 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 14515457 ↗MalfunctionMar 8, 2022Failure 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 Clinical Signs, Symptoms or Conditions
MAUDE report 13694910 ↗MalfunctionDec 29, 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 13109276 ↗MalfunctionDec 22, 2021Mechanical Problem; Mechanical Problem
COMPLAINANT ALLEGED THAT THE DEVICE DISPLAYED "COMPRESSOR FAULT -2001" AND "COMPRESSOR FAULT - 3001" MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13062529 ↗MalfunctionDec 13, 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 12988370 ↗MalfunctionNov 8, 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 12772450 ↗MalfunctionNov 8, 2021Mechanical Problem; Mechanical Problem
COMPLAINANT ALLEGED THAT DURING FUNCTIONAL TESTING, THE DEVICE DISPLAYED A "VALVE FAILURE-1010" 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 12772282 ↗MalfunctionOct 14, 2021Failure 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 Clinical Signs, Symptoms or Conditions
MAUDE report 12633156 ↗MalfunctionOct 7, 2021Failure 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 Clinical Signs, Symptoms or Conditions
MAUDE report 12593280 ↗MalfunctionAug 31, 2021Mechanical Problem; Failure of Device to Self-Test; Mechanical Problem; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING A ROUTINE SHIFT CHECK BY A CLINICIAN, THE DEVICE DISPLAYED "COMPRESSOR FAILURE -1001" AND "SELF CHECK FAILURE -1003" ERROR MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12393111 ↗MalfunctionJun 22, 2021Pressure Problem; Pressure Problem
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, 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 Clinical Signs, Symptoms or Conditions
MAUDE report 12042903 ↗MalfunctionJun 3, 2021Mechanical Problem; Failure of Device to Self-Test; Mechanical Problem; Failure of Device to Self-Test
COMPLAINANT ALLEGED THAT DURING BIOMED TESTING, THE DEVICE DISPLAYED "COMPRESSOR FAILURE -1001", "COMPRESSOR FAULT-2001" AND "SELF CHECK FAILURE -1003" ERROR MESSAGES. COMPLAINANT INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT IN THE REPORTED MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11935117 ↗MalfunctionMay 10, 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 11801175 ↗
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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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