AestivaRecalls & reported problems across all models

We found 2 models of Aestiva by Datex-Ohmeda Inc in the FDA's device registry (GUDID). Together they are named in 158 adverse event reports in the FDA's MAUDE database, received between Apr 2, 2019 and Sep 30, 2026 — classified as 158 malfunctions.

The most frequently reported specific device problem is “Power Problem” (33 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 Aestiva problems

Aestiva models

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

• Aestiva MRI

  Gas-machine, anesthesia
  157 reports
• Aestiva 7900

  Gas-machine, anesthesia
  1 report

Recent Aestiva adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952245 ↗
• MalfunctionSep 24, 2026Insufficient Flow or Under Infusion

  It was reported that there was a malfunction resulting in a leak that could cause insufficient O2. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881084 ↗
• MalfunctionSep 1, 2026Tidal Volume Fluctuations

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50548708 ↗
• MalfunctionJun 23, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION DURING PRE-USE CHECKOUT RESULTING IN INSUFFICIENT O2. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25598598 ↗
• MalfunctionJun 19, 2026Power Problem

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF POWER AND SUBSEQUENT LOSS OF MECHANICAL VENTILATION DURING PRE-USE CHECK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25565226 ↗
• MalfunctionJun 9, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN INSUFFICIENT AGENT DELIVERY DURING PRE-USE CHECKOUT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25450361 ↗
• MalfunctionMay 27, 2026Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN LOSS OF MECHANICAL VENTILATION DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25301488 ↗
• MalfunctionMay 22, 2026Failure to Power Up

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN THE DEVICE COULDN¿T POWER UP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25257047 ↗
• MalfunctionMay 21, 2026Power Problem

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN POWER SUPPLY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250501 ↗
• MalfunctionMay 21, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN MIXER ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250494 ↗
• MalfunctionMay 21, 2026Failure to Run on Battery

  IT WAS REPORTED THAT THERE WAS A BATTERY FAILURE THAT COULD CAUSE LOSS OF MECHANICAL VENTILATION DURING PRE-USE CHECKOUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241506 ↗
• MalfunctionMay 20, 2026Leak/Splash

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN A LEAK DURING PRE-USE CHECKOUT . THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25231130 ↗
• MalfunctionMay 18, 2026Mechanical Problem

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION DURING PRE-USE CHECKOUT RESULTING IN LOSS OF VENTILATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25202726 ↗
• MalfunctionMay 15, 2026Power Problem

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN MACHINE POWER FAILURE. THERE WAS NO PATIENT INVOLVEMENT REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25182527 ↗
• MalfunctionMay 15, 2026Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION RESULTING IN INSUFFICIENT O2 DURING A CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25181156 ↗

Other Datex-Ohmeda Inc products

• TEC4 models · 2,525 reports · 4 recalls
• Aisys2 models · 2,146 reports · 7 recalls
• Aespire2 models · 206 reports · 4 recalls
• TEC 6 PLUS3 models · 147 reports · 1 recall
• Panda2 models · 49 reports · 1 recall