Model Eagle IIRecalls & reported problems across all models

We found 2 models of Model Eagle II by Zoll Medical Corporation in the FDA's device registry (GUDID). Together they are named in 80 adverse event reports in the FDA's MAUDE database, received between Aug 3, 2017 and Nov 26, 2024 — classified as 1 death, 79 malfunctions.

The most frequently reported specific device problem is “Failure of Device to Self-Test” (22 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

Most reported Model Eagle II problems

Model Eagle II models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Model Eagle II 799-EGL2-00-01

  Oximeter
  45 reports
• Model Eagle II 799-EGL2-00

  Oximeter
  1 death35 reports

Recent Model Eagle II adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionNov 8, 2024Failure 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 20640227 ↗
• 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 ↗
• DeathJul 26, 2024Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINANT ALLEGED THAT WHILE ATTEMPTING TO TREAT A PATIENT (AGE & GENDER UNKNOWN), THE DEVICE DISPLAYED AN "AIRWAY PRESSURE HIGH - 2070" ERROR MESSAGE. COMPLAINANT INDICATED THAT THE CLINICIAN ATTEMPTED TO REPLACE THREE OTHER O2 CYLINDERS WITHOUT SUCCESS. THE CLINICIAN THEN BAG VENTILATED TO CONTINUE TREATING THE PATIENT. COMPLAINANT INDICATED THAT THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 19841449 ↗
• 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 ↗
• MalfunctionOct 17, 2023Calibration 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 17948644 ↗
• 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 ↗

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