Savina System 8414450Recalls & reported problems

Summary

The FDA's MAUDE database contains 68 adverse event reports that list this exact device (DI 04048675016403), received between Apr 21, 2017 and May 12, 2026 — classified as 4 injuries, 64 malfunctions.

The most frequently reported specific device problem is “Gas Output Problem” (31 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 68 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Failure to Deliver; Complete Loss of Power; Unexpected Shutdown

  IT WAS REPORTED IN AN UFR TO DRÄGER THAT THE DEVICE SUDDENLY POSTED AN ALARM DURING A RUNNING VENTILATION EPISODE INDICATING A BATTERY CHARGING ERROR AND SHUT DOWN AFTERWARDS. AS PER REPORT, THE USERS CONNECTED THE PATIENT TO ANOTHER DEVICE; NO HEALTH CONSEQUENCES WERE RESULTING FROM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150746 ↗
• MalfunctionApr 22, 2026Insufficient Device Problem Information

  DRÄGER RECEIVED AN UFR STATING THE FOLLOWING: "DURING THE PATIENT'S USE OF THE EQUIPMENT, IT SUDDENLY MALFUNCTIONED AND BECAME INOPERABLE. THE DEVICE WAS IMMEDIATELY REPLACED." 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 24953998 ↗
• MalfunctionApr 9, 2026Insufficient Device Problem Information

  DRÄGER RECEIVED AN UFR IN WHICH IT WAS REPORTED THAT THE DEVICE PERFORMED A REBOOT DURING A RUNNING VENTILATION EPISODE WHEREUPON THE USERS DECIDED TO REPLACE THE DEVICE IN A CONTROLLED MANEUVER. AS PER REPORT, THE VITAL SIGNS OF THE PATIENT REMAINED STABLE THROUGHOUT THE COURSE OF EVENT; NO HEALTH CONSEQUENCES HAVE OCCURRED, FINALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24827245 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ONGOING VENTILATION THE PATIENT APPEARED PALE WITH LOW OXYGEN SATURATION - IMMEDIATE ASSESSMENT REVEALED THE VENTILATOR HAD STOPPED FUNCTIONING - REPORTEDLY AFTER ADJUSTING THE VENTILATOR, NORMAL VENTILATION WAS RESTORED. IT WAS FURTHER REPORTED THAT, AFTER THE FOLLOWING ACTIVE RESUSCITATION, THE PATIENT'S HEART RATE RECOVERED, AND COMPLEXION RETURNED TO NORMAL - PATIENT'S CONDITION WAS CONTINOUSLY MONITORED THEN.

  Patient problems: Low Oxygen Saturation

  MAUDE report 24649535 ↗
• MalfunctionNov 20, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DRÄGER RECEIVED AN UFR WITH THE FOLLOWING DESCRIPTION: "...THE VENTILATOR SCREEN SUDDENLY WENT BLANK AND CEASED FUNCTIONING". AS PER REPORT, THE PATIENT WAS CONNECTED TO ANOTHER DEVICE. 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 23603253 ↗
• MalfunctionSep 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DRAGER RECEIVED AN UFR IN WHICH IT WAS STATED THAT THE DEVICE POSTED AN ALARM DURING USE INDICATING A FAILURE IN THE AMBIENT PRESSURE MEASUREMENT AND SHUT ITSELF OFF IN THE FOLLOWING. THERE WAS NO DETAIL IN THE REPORT WHICH WOULD REASONABLY SUGGEST THAT HEALTH CONSEQUENCES FOR THE PATIENT MAY HAVE RESULTED FROM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993494 ↗
• MalfunctionJul 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE SUDDENLY SHUT DOWN DURING A RUNNING VENTILATION EPISODE AND PERFORMED REPEATED REBOOTS. THE USERS REPORTEDLY REPLACED THE DEVICE IN A CONTROLLED MANEUVER WITH NO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22369333 ↗
• MalfunctionJun 30, 2025Gas Output Problem; Failure to Run on Battery; Decrease in Pressure; Gas Output Problem; Failure to Run on Battery; Decrease in Pressure

  DRÄGER HAS RECEIVED A UFR IN WHICH IT WAS REPORTED THAT THE DEVICE POSTED AN ALARM APPROX. 1 MINUTE AFTER START OF THE PARTICULAR VENTILATION EPISODE AND THAT READINGS/CURVES DISAPPEARED FROM THE DEVICE'S SCREEN. AS PER REPORT, THE USERS HAVE THEREUPON DECIDED TO REPLACE THE DEVICE IN A CONTROLLED MANEUVER WITH NO HEALTH CONSEQUENCES FOR THE PATIENT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22357824 ↗
• MalfunctionJun 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DRÄGER RECEIVED A USER FACILITY REPORT IN WHICH IT WAS DESCRIBED THAT THE DEVICE SUDDENLY SHUT DOWN DURING A RUNNING VENTILATION EPISODE. THE PATIENT REPORTEDLY EXHIBITED A MINOR AND TEMPORARY DESATURATION BUT THERE WAS NO DETAIL IN THE REPORT WHICH WOULD REASONABLY SUGGEST THAT FINAL HEALTH CONSEQUENCES MAY HAVE OCCURRED. THE COMPLETE UNIQUE DEVICE IDENTIFIER (UDI) OF THE AFFECTED PRODUCT COULD NOT BE DETERMINED DUE TO THE MISSING SERIAL NUMBER OF THE DEVICE. WE WILL REQUEST THE SERIAL NUMBER FROM THE CUSTOMER. IF THIS ATTEMPT LEADS TO AN UDI, WE WILL SUBMIT A FOLLOW-UP REPORT.

  Patient problems: Low Oxygen Saturation

  MAUDE report 22334801 ↗
• MalfunctionJun 25, 2025Failure to Deliver; Complete Loss of Power; Unexpected Shutdown; Failure to Deliver; Complete Loss of Power; Unexpected Shutdown

  IT WAS REPORTED THAT THE DEVICE PERFORMED INTERMITTENT REBOOTS DURING A RUNNING VENTILATION EPISODE. THE USERS REPORTEDLY REPLACED THE DEVICE IN A CONTROLLED MANEUVER; HEALTH CONSEQUENCES FOR THE PATIENT DID NOT OCCUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22326772 ↗
• MalfunctionJun 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE INTENSIVE CARE VENTILATOR SUDDENLY POSTED AN ALARM DURING USE, SHUT ITSELF OFF AND COULD NOT BE RESTARTED. AS PER REPORT, THE USERS HAVE CONNECTED THE PATIENT TO ANOTHER DEVICE; NO HEALTH CONSEQUENCES HAVE OCCURRED, FINALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22174005 ↗
• MalfunctionJan 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE USERS BECAME AWARE FROM AN ALARM ISSUED BY THE PATIENT MONITORING SYSTEM THAT THE VENTILATOR WAS NOT WORKING. AS PER REPORT, THE USER INTERFACE OF THE DEVICE WAS FOUND UNRESPONSIVE AND THUS, IT WAS DECIDED TO CONNECT THE PATIENT TO ANOTHER DEVICE INSTEAD. IT WAS STATED THAT THER EVENT DID NOT LEAD TO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21176648 ↗
• MalfunctionJan 9, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE SUDDENLY POSTED A POWER LOSS ALARM AFTER 2 HOURS OF USE AND SHUT DOWN. AS PER REPORT, THE USERS BRIDGED PATIENT SUPPORT WITH AN AMBU BAG UNTIL A REPLACEMENT DEVICE COULD BE INTRODUCED. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE RESULTING FROM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21110645 ↗
• MalfunctionJan 3, 2025Failure to Deliver; Complete Loss of Power; Unexpected Shutdown; Failure to Deliver; Complete Loss of Power; Unexpected Shutdown

  IT WAS REPORTED THAT THE DEVICE SHUT DOWN DURING USE WHILE ALARMING FOR AC POWER FAIL AND COULD NOT BE RESTARTED AFTERWARDS. THE USERS REPORTEDLY CONNECTED THE PATIENT TO ANOTHER DEVICE IMMEDIATELY; NO HEALTH CONSEQUENCES WERE RESULTING FROM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21066035 ↗
• MalfunctionDec 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE SCREEN OF THE DEVICE SUDDENLY WENT BLACK DURING A RUNNING VENTILATION EPISODE. AS PER REPORT, THE USERS REPLACED THE DEVICE IN A CONTROLLED MANEUVER, NO PATIENT CONSEQUENCES WERE RESULTING FROM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20900014 ↗
• InjuryDec 11, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT WHO HAD A SEVERE ACCIDENT RESULTING IN COMA AND SIGNIFICANT DESATURATION WAS CONNECTED TO THE VENTILATOR BUT THAT THE USERS COULD NOT ESTABLISH A SUFFICIENT VENTILATION. THE DEVICE REPORTEDLY POSTED ALARMS INDICATING LOW AIRWAY PRESSURE AND INSUFFICIENT VENTILATION WHEREUPON THE USERS SWITCHED OVER TO MANUAL VENTILATION FIRST AND TRANSFERRED THE PATIENT TO ANOTHER DEVICE AFTERWARDS. PATIENT OUTCOME IS UNKNOWN. AS A SIDE NOTE, THE USER SUSPECTED A MALFUNCTION OF THE "OXYGEN FLOW SENSOR".

  Patient problems: Low Oxygen Saturation

  MAUDE report 20899765 ↗
• MalfunctionNov 19, 2024Gas 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 DEVICE POSTED AN ALARM DURING USE INDICATING A BATTERY FAILURE. AT FIRST THERE WAS NO RESTRICTION IN DEVICE PERFORMANCE BUT THE DEVICE REPORTEDLY STOPPED OPERATION HALF AN HOUR LATER. AS PER REPORT, REBOOTING THE DEVICE COULD INITIALLY RESTORE FUNCTION BUT AFTER ANOTHER HALF HOUR OF OPERATION, THE NEXT SHUTDOWN OCCURRED. THE DEVICE WAS REPLACED IN A CONTROLLED MANEUVER, NO PATIENT CONSEQUENCES HAVE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20722770 ↗
• MalfunctionNov 13, 2024Human-Device Interface Problem; Output Problem; Human-Device Interface Problem; Output Problem

  IT WAS REPORTED THAT THE KEYS OF THE VENTILATOR WERE FOUND TO BE UNRESPONSIVE AND INOPERABLE WHILE BEING IN USE ON A PATIENT. REPORTEDLY, THE VENTILATION WAS NOT AFFECTED AND CONTINUED AS SET. THE DEVICE WAS REPLACED. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20677223 ↗
• MalfunctionOct 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE POSTED AN ALARM DURING USE WHILE THE PATIENT WAS EXPERIENCING A TEMPORARY OXYGEN DESATURATION. AS PER REPORT, THE NURSE COULD NOT IDENTIFY THE ROOT CAUSE FOR THE ALARM AND THUS, DECIDED TO REPLACE THE DEVICE IN A CONTROLLED MANEUVER. PATIENT SUPPORT WAS BRIDGED IN MANUAL VENTILATION IN THE MEANTIME; THE OXYGEN SATURATION WENT UP AGAIN AND NO HEALTH CONSEQUENCES HAVE REPORTEDLY OCCURRED, FINALLY.

  Patient problems: Low Oxygen Saturation

  MAUDE report 20531389 ↗
• MalfunctionAug 1, 2024Decrease in Pressure; Failure to Deliver; Complete Loss of Power; Unexpected Shutdown; Decrease in Pressure; Failure to Deliver; Complete Loss of Power; Unexpected Shutdown

  IT WAS REPORTED THAT THE DEVICE FREQUENTLY RESTARTED AUTOMATICALLY DURING PATIENT USE. THERE WERE NO PATIENT HEALTH CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19881732 ↗
• MalfunctionJul 2, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE SUDDENLY SHUT DOWN DURING USE. AS PER REPORT, THE USERS BRIDGED VENTILATION SUPPORT WITH A MANUAL RESUSCITATOR (AMBU BAG) UNTIL A REPLACEMENT DEVICE WAS MADE AVAILABLE. THE EVENT DID NOT LEAD TO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19653088 ↗
• MalfunctionJun 24, 2024Decrease in Pressure; Failure to Deliver; Complete Loss of Power; Unexpected Shutdown; Decrease in Pressure; Failure to Deliver; Complete Loss of Power; Unexpected Shutdown

  IT WAS REPORTED THAT THE VENTILATOR ALARMED AND EITHER RESTARTED OR SHUT DOWN AUTOMATICALLY DURING USE. THE VENTILATOR WAS IMMEDIATELY REPLACED BY ANOTHER ONE. THERE WERE NO PATIENT HEALTH CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19592530 ↗
• MalfunctionJun 24, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE SUDDENLY POSTED AN ALARM DURING USE WHICH INDICATED A BATTERY FAILURE. THE SYSTEM EFFECT IS NOT CLEAR SINCE THE USER DESCRIBED IT AS: "THE DEVICE WAS RESTARTED OR SHUT DOWN DUE TO BATTERY FAILURE." AS PER REPORT, THE DEVICE WAS REPLACED IN A CONTROLLED MANEUVER IN ABUNDANCE OF CAUTION; NO PATIENT CONSEQUENCES HAVE RESULTED FROM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19592525 ↗
• MalfunctionMay 24, 2024Gas Output Problem; Decreased Pump Speed; Failure to Deliver; Gas Output Problem; Decreased Pump Speed; Failure to Deliver

  IT WAS REPORTED THAT THE VENTILATOR FAILED DURING VENTILATION AND DISPLAYED THE ERROR CODE 42.0002. THE NURSE IMMEDIATELY REPLACED THE VENTILATOR. THE PATIENT¿S OXYGEN SATURATION TEMPORARILY DECREASED BUT STABILIZED AFTER REPLACEMENT OF THE VENTILATOR. NO FURTHER PATIENT HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 19390332 ↗
• MalfunctionApr 29, 2024Device Alarm System; Device Difficult to Program or Calibrate; No Fail-Safe Mechanism; Device Alarm System; Device Difficult to Program or Calibrate; No Fail-Safe Mechanism

  IT WAS REPORTED THAT DURING VENTILATION OF A PATIENT WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE THE DEVICE DISPLAYED THE ALARM MESSAGE "DEVICE FAILURE 54.0001". REPORTEDLY, THE USER WAS UNABLE TO ELIMINATE THE ALARM AND THE DEVICE COULD NOT BE USED. THE DEVICE WAS REPLACED. IT WAS REPORTED THAT THE PATIENT'S BODY FUNCTION AND THE PATIENT'S TREATMENT PROCESS WERE IMPAIRED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19201071 ↗