Savina 300 8417800Recalls & reported problems

Summary

The FDA's MAUDE database contains 220 adverse event reports that list this exact device (DI 04048675251422), received between Apr 21, 2017 and Sep 30, 2026 — classified as 7 deaths, 7 injuries, 206 malfunctions.

The most frequently reported specific device problem is “Gas Output Problem” (97 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 220 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Device Difficult to Program or Calibrate

  It was reported that it had been impossible to change the ventilation modes while a patient was connected and that the rotary knob had likewise not worked. No patient health consequences have been reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50943435 ↗
• MalfunctionJun 30, 2026Insufficient Device Problem Information

  DRÄGER RECEIVED AN UFR IN WHICH IT WAS STATED THAT THE HOSPITAL STAFF NOTICED DURING A ROUND TO THE WARD THAT THE VENTILATOR HAD SHUT DOWN. AS PER REPORT, THE DEVICE WAS IMMEDIATELY REPLACED WHICH PREVENTED FROM HEALTH CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25663733 ↗
• MalfunctionJun 12, 2026Insufficient Device Problem Information

  DRÄGER RECEIVED AN UFR WITH THE FOLLOWING DESCRIPTION: "THE PATIENT WAS USING THE VENTILATOR WHEN THE DISPLAY SCREEN SUDDENLY WENT BLACK. IMMEDIATELY REPORTED TO THE DEVICE DEPARTMENT FOR REPAIR, AND REPLACED WITH ANOTHER VENTILATOR." THERE WAS NO DETAIL IN THE REPORT WHICH WOULD REASONABLY SUGGEST THAT HEALTH CONSEQUENCES FOR THE PATIENT MAY HAVE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25481654 ↗
• DeathJun 10, 2026Failure to Run on Battery; Failure to Deliver; Complete Loss of Power

  IT WAS REPORTED THAT ON (B)(6) AT 11:40 PM, WHILE THE SAVINA 300 WAS ON STANDBY, IT WAS MOVED TO THE PATIENT'S BEDSIDE WITH THE POWER CORD UNPLUGGED AND NOT RECONNECTED. AT 11:58 PM, VENTILATION FOR THE PATIENT WAS STARTED. ON MAY 6, AT 0:41 AM, A "BATTERY BELOW 10%" ALARM OCCURRED, AND THE DEVICE SUBSEQUENTLY SHUT DOWN. AT 0:53 AM, THE POWER CORD WAS RECONNECTED, AND VENTILATION WAS RESUMED. IT WAS REPORTED THAT THE PATIENT HAD PASSED AWAY.

  Patient problems: Insufficient Information

  MAUDE report 25456900 ↗
• MalfunctionMay 29, 2026Insufficient Device Problem Information

  IT WAS REPORTED IN AN UFR TO DRÄGER THAT THE SCREEN OF THE VENTILATOR SUDDENLY TURNED BLACK DURING USE AND THAT VENTILATION STOPPED. AS PER REPORT, THE USERS BRIDGED PATIENT SUPPORT WITH A MANUAL BREATHING BAG UNTIL A REPLACEMENT DEVICE COULD BE INTRODUCED; IT WAS STATED THAT THE EVENT DID NOT LEAD TO HEALTH CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25326870 ↗
• MalfunctionMay 28, 2026Gas Output Problem; Decrease in Pressure; Reset Problem

  IT WAS REPORTED THAT ON MARCH 22 9:58P, THE UNIT SHUTDOWN WHILE IN USE. NO REPORTED PATIENT INJURY, THE PATIENT WAS MANUALLY VENTILATED AND MOVED TO ANOTHER VENTILATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25313939 ↗
• MalfunctionMay 27, 2026Gas Output Problem; Failure to Run on Battery; Decrease in Pressure

  DRÄGER RECEIVED AN UFR IN WHICH IT WAS REPORTED THAT THE DEVICE PERFORMED A REBOOT DURING USE. VENTILATION WAS REPORTEDLY CONTINUED AFTER THE REBOOT BUT THE OPERATORS DECIDED TO REPLACE THE DEVICE IN A CONTROLLED MANEUVER IN ABUNDANCE OF CAUTION. NO HEALTH CONSEQUENCES FOR THE PATIENT HAVE OCCURRED. IT WAS FURTHER MENTIONED THAT THE DEVICE IS BACK IN USE AFTER EXCHANGE OF THE INTERNAL BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25300719 ↗
• MalfunctionMay 18, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE SUDDENLY POSTED A HIGH-PRIORITY ALARM DURING A RUNNING VENTILATION EPISODE. AS PER REPORT, THE PATIENT EXHIBITED A TEMPORARY DESATURATION BUT THE SPO2 LEVEL RETURNED TO NORMAL AFTER INTRODUCTION OF A REPLACEMENT DEVICE. IT WAS EXPLICITLY STATED THAT NO HEALTH CONSEQUENCES FOR THE PATIENT WERE RESULTING FROM THE EVENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 25199983 ↗
• MalfunctionMay 18, 2026Gas Output Problem; Decrease in Pressure; Data Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, DURING PATIENT USE, THE DEVICE RESTARTED WHILE THE VENTILATION SETTINGS WERE BEING CHANGED AND DEVICE FAILURE 16.3010 OCCURRED. NO PATIENT HEALTH CONSEQUENCES HABE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25199980 ↗
• MalfunctionMay 12, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING USE ON A PATIENT THE VENTILATOR SUDDENLY CEASED OPERATION ON ITS OWN. THE VENTILATOR SCREEN DISPLAYED A FLAT WAVEFORM, INDICATING EXCESSIVELY LOW AIRWAY PRESSURE AND FAILURE TO DELIVER AIR. REPORTEDLY THE USERS CHECKED ALL CONNECTIONS BUT DECIDED THEN TO REPLACE THE DEVICE BY A BACK-UP VENTILATOR - PATIENT'S VITAL SIGNS REMAINED STABLE - NO SERIOUS INJURY OR FURTHER IMPAIRMENT OF PATIENT'S STATE OF HEALTH WITH RESPECT TO THIS EVENT WAS BEING INDICATED.

  Patient problems: Insufficient Information

  MAUDE report 25152082 ↗
• MalfunctionApr 30, 2026Failure to Read Input Signal; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN EXCHANGE THE DEVICE ALARMED AN ALARM OF THE FIO2 SENSOR. THE PATIENT WHO WAS JUST CONNECTED REQUIRED RESUSCITATIVE EFFORTS. THE PATIENT RECOVERED. NO FURTHER CONSEQUENCES WERE REPORTED.

  Patient problems: Arrhythmia; Dyspnea

  MAUDE report 25041593 ↗
• MalfunctionApr 29, 2026Gas Output Problem; Failure to Deliver; No Apparent Adverse Event; Activation Failure

  IT WAS REPORTED THAT THE DEVICE HAD TO BE REPLACED AS IT WAS TURNING OFF DURING PATIENT USE. NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25027521 ↗
• MalfunctionApr 24, 2026No Display/Image; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE SCREEN WENT BLANK WHILE VENTILATING. NURSE WAS AT THE BEDSIDE WHEN THE PROBLEM OCCURRED. VENTILATOR WAS STILL DELIVERING BREATHS WHILE IN USE. NO PAT. HEALTH CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24978998 ↗
• MalfunctionApr 16, 2026Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THERE WAS A FAILURE OF THE TOUCH SCREEN, AND IT WAS DIFFICULT TO DO THE SETTINGS. IT IS IMPOSSIBLE TO CHANGE VENTILATION MODE WHEN A PATIENT IS CONNECTED. THE ROTARY KNOB DOES NOT WORK EITHER. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24902417 ↗
• MalfunctionApr 9, 2026Insufficient Device Problem Information

  DRÄGER RECEIVED AN UFR FILED AGAINST AN INTENSIVE CARE VENTILATOR SIMPLY STATING: "BLACK SCREEN DURING USE. ACTION: REPAIR." THERE WAS NO DETAIL IN THE REPORT WHICH WOULD REASONABLY SUGGEST THAT PATIENT CONSEQUENCES MAY HAVE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24827241 ↗
• MalfunctionMar 30, 2026Gas Output Problem; Failure to Run on Battery; Decrease in Pressure

  IT WAS REPORTED THAT THE VENTILATOR EXPERIENCED INTERMITTENT BLACK SCREEN AND SHUTDOWN DURING USE. THERE WAS NO FURTHER INFORMATION ABOUT PATIENT INVOLVEMENT, ANY FOLLOW-UP ACTIONS OR AN IMPAIRMENT TO PATIENT'S HEALTH REPORTED. THE EVENT WAS REPORTED BY THE USER FACILITY TO THE NATIONAL AUTHORITY ONLY.

  Patient problems: Insufficient Information

  MAUDE report 24710457 ↗
• MalfunctionMar 25, 2026Gas Output Problem; Failure to Run on Battery; Failure to Deflate

  IT WAS REPORTED THAT DURING USE ON A PATIENT THE VENTILATOR SCREEN SUDDENLY BLACKED OUT AND THE DEVICE AUTOMATICALLY REBOOTED TWICE. THE PATIENT WAS THEN CONNECTED TO A SPARE DEVICE - NO INJURY OR SERIOUS IMPAIRMENT OF PATIENTS STATE OF HEALTH WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24687413 ↗
• MalfunctionMar 24, 2026Device Difficult to Program or Calibrate; Human-Device Interface Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS A FAILURE OF THE TOUCH SCREEN, AND IT WAS DIFFICULT TO DO THE SETTINGS. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24672918 ↗
• InjuryJan 19, 2026Insufficient Device Problem Information

  DRÄGER RECEIVED AN UFR WITH THE FOLLOWING STATEMENT: "WHILE ADMINISTERING 100% PURE OXYGEN TO THE PATIENT, THE VENTILATOR DISPLAYED A LOW OXYGEN SUPPLY ALERT. DURING THIS TIME, THE PATIENT'S OXYGEN SATURATION DROPPED FROM 98% TO 80%, AND CYANOSIS WAS OBSERVED. THE VENTILATOR WAS REPLACED, AND THE PURE OXYGEN BUTTON WAS PRESSED, AFTER WHICH NO FURTHER LOW OXYGEN SUPPLY ALERTS APPEARED. MACHINE CAUSE: EXCESSIVE OXYGEN CONSUMPTION BY THE VENTILATOR TUBING, RESULTING IN INSUFFICIENT OXYGEN SUPPLY CAPACITY."

  Patient problems: Low Oxygen Saturation

  MAUDE report 24109025 ↗
• MalfunctionJan 16, 2026Gas Output Problem; Failure to Run on Battery; Decrease in Pressure

  DRÄGER RECEIVED AN UFR IN WHICH IT WAS STATED THAT THE DEVICE ALARMED APPROX. 1 HOUR AFTER START OF A VENTILATION EPISODE FOR "INTERNAL BATTERY MISSING" AND PERFORMED A SHUT-DOWN. AS PER REPORT, THE DEVICE WAS REPLACED IN A CONTROLLED MANEUVER WITH NO CONSEQUENCES FOR THE PATIENT. IT WAS FURTHER STATED THAT THE DEVICE IS BACK IN USE AFTER REPLACEMENT OF THE INTERNAL BATTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24091608 ↗
• MalfunctionJan 9, 2026Failure to Deliver; Complete Loss of Power; Unexpected Shutdown

  DRÄGER RECEIVED AN UFR WITH THE FOLLOWING STATEMENT: "THE VENTILATOR SUDDENLY LOST POWER AND SHUT DOWN; IMMEDIATELY SWITCHED TO ANOTHER VENTILATOR FOR USE". THERE WAS NO DETAIL IN THE REPORT WHICH WOULD SUGGEST THAT PATIENT CONSEQUENCES MAY HAVE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24017757 ↗
• MalfunctionJan 8, 2026Gas Output Problem; Failure to Run on Battery; Decrease in Pressure

  IT WAS REPORTED THAT THE DEVICE SUDDENLY PERFORMED A REBOOT DURING A RUNNING VENTILATION EPISODE. THE USERS DECIDED TO REPLACE THE DEVICE IN A CONTROLLED MANEUVER. THE EVENT DID NOT LEAD TO HEALTH CONSEQUENCES FOR THE PATIENT, FINALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24001050 ↗
• MalfunctionDec 17, 2025Gas Output Problem; Failure to Run on Battery; Decrease in Pressure; Gas Output Problem; Failure to Run on Battery; Decrease in Pressure

  IT WAS REPORTED TO DRÄGER THAT THE VENTILATOR SUDDENLY PERFORMED CONSECUTIVE REBOOTS DURING A RUNNING VENTILATION EPISODE AND HAD TO BE REPLACED. THE EVENT ITSELF AND THE EXCHANGE MANEUVER WERE REPORTEDLY NOT RESULTING IN HEALTH CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825705 ↗
• MalfunctionDec 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DRÄGER RECEIVED AN UFR IN WHICH THE FOLLOWING WAS STATED: "DURING THE TREATMENT OF A PATIENT, THE ANESTHESIOLOGIST OBSERVED A DECLINE IN THE PATIENT'S BLOOD OXYGEN SATURATION. UPON INSPECTING THE EQUIPMENT, IT WAS DISCOVERED THAT THE OXYGEN CONCENTRATION HAD DECREASED."

  Patient problems: Low Oxygen Saturation

  MAUDE report 23759355 ↗
• MalfunctionDec 9, 2025Gas Output Problem; Decrease in Pressure; Reset Problem; Gas Output Problem; Decrease in Pressure; Reset Problem

  IT WAS REPORTED THAT THE DEVICE SHUT DOWN AND ALARMED DEVICE FAILURE WHILE ON A PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23754526 ↗