Fabius GS premium 8607000Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 04048675041467), received between Sep 28, 2016 and Mar 25, 2026 — classified as 1 injury, 54 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (42 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 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Device Handling Problem

  IT WAS REPORTED THAT DUE TO A DISCONNECTED PRESSURE HOSE ON THE BACK OF THE MACHINE A VENTILATOR FAILURE OCCURRED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686270 ↗
• MalfunctionNov 25, 2025Degraded; Failure to Deliver; No Pressure; Degraded; Failure to Deliver; No Pressure

  IT WAS REPORTED THAT A VENT FAIL OCCURRED DURING USE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23643079 ↗
• MalfunctionSep 17, 2025Gas Output Problem; Failure to Deliver; Pressure Problem; Gas Output Problem; Failure to Deliver; Pressure Problem

  IT WAS REPORTED THAT A VENTILATOR FAILURE OCCURRED DURING USE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23070799 ↗
• MalfunctionSep 15, 2025Gas Output Problem; Failure to Deliver; Improper Flow or Infusion; Pressure Problem; Gas Output Problem; Failure to Deliver; Improper Flow or Infusion; Pressure Problem

  IT WAS REPORTED THAT THE DEVICE HAD A VENTILATOR FAILURE DURING A CASE, NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23049499 ↗
• MalfunctionSep 15, 2025Gas Output Problem; Failure to Sense; Use of Device Problem; Failure to Deliver; No Apparent Adverse Event; Gas Output Problem; Failure to Sense; Use of Device Problem; Failure to Deliver; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING USE OF THE INVOLVED FABIUS GS PREMIUM THE PRESSURE SUPPORT AND SIMV/PS DID NOT DELIVER A RESPIRATORY RATE NO MATTER WHAT RATE WAS SET. IT HAPPENED ON THREE CASES ON THE REPORTED DAY AND REPORTEDLY IT WORKED FINE USING THE VOLUME CONTROL MODE. THE LOGFILE AND FURTHER INFORMATION HAVE BEEN PROVIDED TO THE MANUFACTURER. BASED ON THE INITIAL LOGBOOK ANALYSIS, NO EVIDENCE OF A DEVICE MALFUNCTION WAS IDENTIFIED. MOST LIKELY, USER SETTINGS WERE RESPONSIBLE FOR THE REPORTED ISSUE. NEVERTHELESS, A DEVICE MALFUNCTION CANNOT BE EXCLUDED WITH CERTAINTY. THEREFORE, THIS REPORT HAS BEEN SUBMITTED AS A PRECAUTION. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23049496 ↗
• MalfunctionSep 5, 2025Gas Output Problem; Failure to Deliver; Pressure Problem; Gas Output Problem; Failure to Deliver; Pressure Problem

  IT WAS REPORTED THAT THE DEVICE SUDDENLY POSTED A VENT FAIL ALARM AND SHUT DOWN AUTOMATIC VENTILATION. IT WAS EXPLICITLY MENTIONED THAT THE EVENT DID NOT LEAD TO HEALTH CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22975224 ↗
• MalfunctionSep 5, 2025Gas Output Problem; Failure to Sense; Use of Device Problem; Failure to Deliver; No Apparent Adverse Event; Gas Output Problem; Failure to Sense; Use of Device Problem; Failure to Deliver; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING USE OF THE INVOLVED FABIUS GS PREMIUM THE PRESSURE SUPPORT AND SIMV/PS DID NOT DELIVER A RESPIRATORY RATE NO MATTER WHAT RATE WAS SET. IT HAPPENED ON THREE CASES ON THE REPORTED DAY AND REPORTEDLY IT WORKED FINE USING THE VOLUME CONTROL MODE. THE LOGFILE AND FURTHER INFORMATION HAVE BEEN PROVIDED TO THE MANUFACTURER. BASED ON THE INITIAL LOGBOOK ANALYSIS, NO EVIDENCE OF A DEVICE MALFUNCTION WAS IDENTIFIED. MOST LIKELY, USER SETTINGS WERE RESPONSIBLE FOR THE REPORTED ISSUE. NEVERTHELESS, A DEVICE MALFUNCTION CANNOT BE EXCLUDED WITH CERTAINTY. THEREFORE, THIS REPORT HAS BEEN SUBMITTED AS A PRECAUTION. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22975159 ↗
• MalfunctionSep 5, 2025Gas Output Problem; Failure to Sense; Use of Device Problem; Failure to Deliver; No Apparent Adverse Event; Gas Output Problem; Failure to Sense; Use of Device Problem; Failure to Deliver; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING USE OF THE INVOLVED FABIUS GS PREMIUM THE PRESSURE SUPPORT AND SIMV/PS DID NOT DELIVER A RESPIRATORY RATE NO MATTER WHAT RATE WAS SET. IT HAPPENED ON THREE CASES ON THE REPORTED DAY AND REPORTEDLY IT WORKED FINE USING THE VOLUME CONTROL MODE. THE LOGFILE AND FURTHER INFORMATION HAVE BEEN PROVIDED TO THE MANUFACTURER. BASED ON THE INITIAL LOGBOOK ANALYSIS, NO EVIDENCE OF A DEVICE MALFUNCTION WAS IDENTIFIED. MOST LIKELY, USER SETTINGS WERE RESPONSIBLE FOR THE REPORTED ISSUE. NEVERTHELESS, A DEVICE MALFUNCTION CANNOT BE EXCLUDED WITH CERTAINTY. THEREFORE, THIS REPORT HAS BEEN SUBMITTED AS A PRECAUTION. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22975158 ↗
• MalfunctionSep 5, 2025Gas Output Problem; Failure to Sense; Use of Device Problem; Failure to Deliver; No Apparent Adverse Event; Gas Output Problem; Failure to Sense; Use of Device Problem; Failure to Deliver; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING USE OF THE INVOLVED FABIUS GS PREMIUM THE PRESSURE SUPPORT AND SIMV/PS DID NOT DELIVER A RESPIRATORY RATE NO MATTER WHAT RATE WAS SET. IT HAPPENED ON THREE CASES ON THE REPORTED DAY AND REPORTEDLY IT WORKED FINE USING THE VOLUME CONTROL MODE. THE LOGFILE AND FURTHER INFORMATION HAVE BEEN PROVIDED TO THE MANUFACTURER. BASED ON THE INITIAL LOGBOOK ANALYSIS, NO EVIDENCE OF A DEVICE MALFUNCTION WAS IDENTIFIED. MOST LIKELY, USER SETTINGS WERE RESPONSIBLE FOR THE REPORTED ISSUE. NEVERTHELESS, A DEVICE MALFUNCTION CANNOT BE EXCLUDED WITH CERTAINTY. THEREFORE, THIS REPORT HAS BEEN SUBMITTED AS A PRECAUTION. THERE WAS NO PATIENT INJURY REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22975157 ↗
• MalfunctionAug 15, 2025Premature Discharge of Battery; Failure to Deliver; Complete Loss of Power; Premature Discharge of Battery; Failure to Deliver; Complete Loss of Power

  DRÄGER RECEIVED AN UFR WITH THE FOLLOWING CONTENT: "AFTER ROUTINE ANESTHESIA INDUCTION, THE ANESTHESIA MACHINE WAS CONNECTED FOR MECHANICAL VENTILATION. AT 15:30, AFTER THE EXTERNAL POWER SUPPLY WAS DISCONNECTED, THE ANESTHESIA MACHINE DISPLAYED A BATTERY MALFUNCTION AND MECHANICAL VENTILATION BECAME UNAVAILABLE...A MANUAL RESUSCITATION BAG WAS IMMEDIATELY CONNECTED TO THE ENDOTRACHEAL TUBE FOR VENTILATION, AND THE ENGINEERING DEPARTMENT WAS NOTIFIED TO ACTIVATE THE BACKUP POWER SUPPLY." IT WAS MENTIONED THAT THE USER SAW A CERTAIN RISK TO PATIENT SAFETY IN THE EVENT BUT THERE WAS NO DETAIL IN THE REPORT WHICH WOULD REASONABLY SUGGEST THAT HEALTH CONSEQUENTLY HAVE OCCURRED AS A DIRECT CONSEQUENCE FROM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22813781 ↗
• MalfunctionAug 15, 2025Premature Discharge of Battery; Failure to Deliver; Complete Loss of Power; Premature Discharge of Battery; Failure to Deliver; Complete Loss of Power

  DRÄGER RECEIVING AN UFR WITH THE FOLLOWING CONTENT: "AFTER ROUTINE ANESTHESIA INDUCTION, THE ANESTHESIA MACHINE WAS CONNECTED FOR MECHANICAL VENTILATION. AT 15:30, AFTER THE EXTERNAL POWER SUPPLY WAS DISCONNECTED, THE ANESTHESIA MACHINE DISPLAYED A BATTERY MALFUNCTION AND MECHANICAL VENTILATION BECAME UNAVAILABLE. EMERGENCY PROTOCOLS WERE IMMEDIATELY ACTIVATED, UTILIZING AN AMBU BAG CONNECTED TO THE ENDOTRACHEAL TUBE FOR VENTILATION. THE ENGINEERING DEPARTMENT WAS NOTIFIED TO SWITCH TO BACKUP POWER." IT WAS MENTIONED THAT THE USER SAW A CERTAIN RISK TO PATIENT SAFETY IN THE EVENT BUT THERE WAS NO DETAIL IN THE REPORT WHICH WOULD REASONABLY SUGGEST THAT HEALTH CONSEQUENTLY HAVE OCCURRED AS A DIRECT CONSEQUENCE FROM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22813777 ↗
• MalfunctionAug 7, 2025Degraded; Failure to Deliver; No Pressure; Degraded; Failure to Deliver; No Pressure

  IT WAS REPORTED THAT THE VENTILATOR STOPPED WHILE IN A CASE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22736369 ↗
• MalfunctionJul 1, 2025Gas Output Problem; Failure to Deliver; Pressure Problem; Gas Output Problem; Failure to Deliver; Pressure Problem

  IT WAS REPORTED THAT THE DEVICE STOPPED VENTILATING DURING USE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22369335 ↗
• MalfunctionJun 11, 2025Decrease in Pressure; Failure to Deliver; Inaccurate Delivery; Gas/Air Leak; Decrease in Pressure; Failure to Deliver; Inaccurate Delivery; Gas/Air Leak

  IT WAS REPORTED THAT MAN/SPONT WAS NOT WORKING AS BAG WON'T FILL. LOG ANALYSIS REVEALED THAT A VENTILATOR FAILURE OCCURRED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22183301 ↗
• MalfunctionMay 8, 2025Device Reprocessing Problem; Gas Output Problem; Failure to Deliver; Device Reprocessing Problem; Gas Output Problem; Failure to Deliver

  IT WAS FOUND THAT DURING A CASE ON (B)(6) 2025 THE DEVICE WENT TO A VENT FAIL. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21983396 ↗
• MalfunctionApr 23, 2025Gas Output Problem; Failure to Deliver; Gas Output Problem; Failure to Deliver

  IT WAS REPORTED THAT DURING A CASE ON (B)(6) 2025 THE DEVICE WENT TO A VENT FAIL AND THERE WAS NO TIDAL VOLUME OR PRESSURE READINGS. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21889398 ↗
• MalfunctionJan 15, 2025Disconnection; Detachment of Device or Device Component; Device Fell; Disconnection; Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED THAT THE DRAWER FELL OFF AS IT WAS OPENED. NO INJURY REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 21156685 ↗
• MalfunctionJan 9, 2025Gas Output Problem; Failure to Deliver; Pressure Problem; Gas Output Problem; Failure to Deliver; Pressure Problem

  IT WAS REPORTED THAT THE DEVICE EXHIBITED A VENTILATOR FAILURE DURING A RUNNING SURGERY. AS PER REPORT, NO HEALTH CONSEQUENCES FOR THE PATIENT RESULTED FROM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21117993 ↗
• MalfunctionDec 18, 2024Gas Output Problem; Decreased Pump Speed; Failure to Deliver; Gas Output Problem; Decreased Pump Speed; Failure to Deliver

  IT WAS REPORTED THAT MECHANICAL VENTILATION FAILED DURING USE. THE DEVICE GENERATED A CORRESPONDING ALARM. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20967036 ↗
• MalfunctionDec 3, 2024Degraded; Gas Output Problem; Failure to Deliver; No Pressure; Degraded; Gas Output Problem; Failure to Deliver; No Pressure

  IT WAS REPORTED THAT AFTER STARTING INDUCTION TO PATIENT AN "VENTILATOR FAILURE" OCCURRED. PATIENT WAS VENTILATED MANUALLY. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20829363 ↗
• MalfunctionNov 19, 2024Disconnection; Detachment of Device or Device Component; Device Fell; Disconnection; Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED THAT THE BOTTOM DRAWER OF THE FABIUS GS PREMIUM WAS FALLING OUT. NO INJURY REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20721679 ↗
• MalfunctionNov 19, 2024Disconnection; Detachment of Device or Device Component; Device Fell; Disconnection; Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED THAT THE BOTTOM DRAWER OF THE FABIUS GS PREMIUM WAS FALLING OUT. NO INJURY REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20721670 ↗
• MalfunctionNov 13, 2024Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE DEVICE FAILED DURING SURGERY AND THE VENTILATION WAS STOPPED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674070 ↗
• MalfunctionOct 10, 2024Gas Output Problem; Failure to Deliver; Gas Output Problem; Failure to Deliver

  IT WAS REPORTED THAT THE VT READINGS DROPPED VERY LOW DURING A CASE. THE PATIENT WAS VENTILATED MANUALLY FOR A SHORT BIT BEFORE MECHANICAL VENTILATION WAS CONTINUED. IT REPORTEDLY WORKED FOR A SHORT TIME AND THEN THE READINGS WENT VERY LOW AGAIN. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20416635 ↗
• MalfunctionSep 2, 2024Gas Output Problem; Failure to Deliver; Pressure Problem; Gas Output Problem; Failure to Deliver; Pressure Problem

  IT WAS REPORTED THAT UNIT HAD A VENT FAILURE DURING USE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20118238 ↗