Fabius Tiro 8606000Recalls & reported problems

Summary

The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 04048675041474), received between Sep 21, 2017 and Apr 27, 2026 — classified as 3 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (35 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Degraded; Failure to Deliver; No Pressure

  IT WAS REPORTED THAT AUTOMATIC VENTILATION FAILED DURING USE WHEREUPON THE USERS DECIDED TO REPLACE THE DEVICE. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE RESULTING FROM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24996496 ↗
• MalfunctionApr 22, 2026Degraded; Gas Output Problem; Failure to Deliver; No Pressure

  THE USER REPORTED A VENTILATOR ERROR DURING OPERATION IN VOLUME-CONTROLLED VENTILATION MODE. MON/SPONT VENTILATION WAS WORKING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24953997 ↗
• MalfunctionFeb 5, 2026Degraded; Failure to Deliver; No Pressure

  IT WAS REPORTED TO DRÄGER THAT AUTOMATIC VENTILATION FAILED DURING USE. IT WAS CONFIRMED THAT THE DEVICE POSTED A CORRESPONDING ALARM AND THAT THE EVENT DID NOT LEAD TO HEALTH CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24266648 ↗
• MalfunctionJan 23, 2026Degraded; Failure to Deliver; No Pressure

  IT WAS REPORTED TO DRÄGER THAT AUTOMATIC VENTILATION SUDDENLY FAILED DURING A SURGICAL PROCEDURE AND THAT RESTARTING THE ANESTHESIA WORKSTATION DID NOT REMEDY THE ERROR CONDITION. THE DEVICE WAS REPLACED; IT WAS CONFIRMED THAT NO PATIENT CONSEQUENCES WERE RESULTING FROM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24159397 ↗
• MalfunctionDec 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED IN AN UFR THAT THE ANESTHESIA WORKSTATION SUDDENLY SHUT-DOWN AUTOMATIC VENTILATION DURING A SURGICAL PROCEDURE. AS PER REPORT, THE USERS BRIDGED PATIENT SUPPORT WITH A MANUAL RESUSCITATION BAG AND INTRODUCED ANOTHER ANESTHESIA DEVICE THEN. AS PER REPORT, THE EVENT DID NOT LEAD TO HEALTH CONSEQUENCES FOR THE PATIENT. IT WAS FURTHER MENTIONED THAT THE INITIALLY USED DEVICE WAS RESTARTED WHEREBY NORMAL FUNCTION COULD BE RESTORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23874787 ↗
• MalfunctionDec 10, 2025Gas Output Problem; Failure to Deliver; Physical Resistance/Sticking; Gas Output Problem; Failure to Deliver; Physical Resistance/Sticking

  IT WAS REPORTED THAT CO2 INCREASED WHEN USING FABIUS TIRO ON A PATIENT. NO INJURY REPORTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23766482 ↗
• MalfunctionDec 5, 2025Degraded; Failure to Deliver; No Pressure; Degraded; Failure to Deliver; No Pressure

  IT WAS REPORTED TO DRÄGER THAT THE DEVICE SUDDENLY ALARMED DURING A SURGICAL PROCEDURE AND THAT AUTOMATIC VENTILATION STOPPED. THE TEAM FINISHED THE PROCEDURE IN MANUAL VENTILATION WITH NO HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23726191 ↗
• MalfunctionNov 19, 2025Gas Output Problem; Failure to Deliver; Pressure Problem; Gas Output Problem; Failure to Deliver; Pressure Problem

  IT WAS REPORTED THAT THE DEVICE POSTED A VENTILATOR FAIL ALARM DURING USE. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23591774 ↗
• MalfunctionOct 8, 2025Degraded; Gas Output Problem; Failure to Deliver; No Pressure; Degraded; Gas Output Problem; Failure to Deliver; No Pressure

  IT WAS REPORTED THAT WHEN SWITCHING TO MECHANICAL VENTILATION, THE ANESTHESIA MACHINE FAILED TO PROVIDE MECHANICAL VENTILATION, TRIGGERING AN ALARM WITH THE MESSAGE: "APNEA VENTILATION". AFTER SHUTTING DOWN AND RESTARTING THE MACHINE, IT BACKED TO NORMAL USE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23243736 ↗
• MalfunctionOct 8, 2025Degraded; Gas Output Problem; Failure to Deliver; No Pressure; Degraded; Gas Output Problem; Failure to Deliver; No Pressure

  IT WAS REPORTED THAT WHEN SWITCHING TO MECHANICAL VENTILATION, THE ANESTHESIA MACHINE FAILED TO PROVIDE MECHANICAL VENTILATION, TRIGGERING AN ALARM WITH THE MESSAGE: "APNEA VENTILATION". AFTER SHUTTING DOWN AND RESTARTING THE MACHINE, IT BACKED TO NORMAL USE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23243735 ↗
• MalfunctionSep 18, 2025Degraded; Failure to Deliver; No Pressure; Degraded; Failure to Deliver; No Pressure

  IT WAS REPORTED THAT THE ANESTHESIA WORKSTATION SUDDENLY POSTED AN ALARM DURING USE AND SHUT DOWN AUTOMATIC VENTILATION. THE EVENT DID NOT LEAD TO CONSEQUENCES FOR THE PATIENT; VENTILATION SUPPORT WAS BRIDGED IN MANUAL VENTILATION MODE VIA THE BUILT-IN BREATHING BAG FIRST UNTIL A REPLACEMENT DEVICE COULD BE INTRODUCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23081641 ↗
• MalfunctionSep 18, 2025Degraded; Failure to Deliver; No Pressure; Degraded; Failure to Deliver; No Pressure

  IT WAS REPORTED THAT THE ANESTHESIA WORKSTATION SUDDENLY POSTED AN ALARM DURING USE AND SHUT DOWN AUTOMATIC VENTILATION. THE EVENT DID NOT LEAD TO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23081640 ↗
• MalfunctionSep 4, 2025Gas Output Problem; Failure to Deliver; Protective Measures Problem; Gas Output Problem; Failure to Deliver; Protective Measures Problem

  DRÄGER RECEIVED AN UFR IN WHICH IT WAS STATED THAT THE ANESTHESIA WORKSTATION PASSED THE PRE-USE CHECK WITHOUT DEVIATION AND THAT THE INITIAL PART OF THE SURGERY WENT UNEVENTFUL BUT THAT AUTOMATIC VENTILATION DID NOT WORK ANYMORE AFTER REPOSITIONING THE PATIENT. PATIENT SUPPORT WAS REPORTEDLY BRIDGED WITH AN AMBU BAG UNTIL A REPLACEMENT DEVICE WAS MADE AVAILABLE. IT WAS EXPLICITLY STATED THAT THE EVENT DID NOT LEAD TO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22961154 ↗
• MalfunctionJul 18, 2025Degraded; Failure to Deliver; Impedance Problem; Degraded; Failure to Deliver; Impedance Problem

  IT WAS REPORTED THAT THE DEVICE RESTARTED DURING INDUCTION OF ANESTHESIA AND MASK VENTILATION. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22539808 ↗
• MalfunctionJul 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DRÄGER RECEIVED AN UFR IN WHICH THE FOLLOWING WAS STATED: " DURING USE, THE DEVICE SUDDENLY STOPPED FUNCTIONING, WITH THE FLOW SENSOR MALFUNCTIONING. IT WAS IMMEDIATELY REPLACED WITH ANOTHER ANESTHESIA MACHINE." IT WAS MENTIONED THAT THE EVENT DID NOT LEAD TO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505520 ↗
• MalfunctionJul 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DRÄGER RECEIVED AN UFR IN WHICH THE FOLLOWING WAS STATED: "AROUND 2:00 PM ON (B)(6) 2025, THE ANESTHESIA MACHINE SUDDENLY STOPPED FUNCTIONING DURING THE PATIENT'S ANESTHESIA PROCEDURE DUE TO INTERNAL CIRCUIT BOARD DAMAGE." IT WAS MENTIONED THAT THE EVENT DID NOT LEAD TO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22477882 ↗
• MalfunctionApr 9, 2025Degraded; Failure to Deliver; No Pressure; Degraded; Failure to Deliver; No Pressure

  IT WAS REPORTED THAT A VENT FAIL OCCURRED DURING USE. THE CASE WAS FINISHED PATIENT BREATHING SPONTANEOUSLY. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21804238 ↗
• MalfunctionMar 31, 2025Degraded; Failure to Deliver; No Pressure; Degraded; Failure to Deliver; No Pressure

  IT WAS REPORTED THAT THE UNIT HAD A VENTILATOR FAILURE AT THE START OF THE CASE, THE UNIT WAS REBOOTED AND STAFF WAS ABLE TO FINISH THE CASE. NO PATIENT INJURY RESULTING FROM THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729717 ↗
• MalfunctionJan 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE SUDDENLY POSTED A "VENTILATOR FAILURE" ALARM DURING A RUNNING SURGERY AND THAT AUTOMATIC VENTILATION WAS SHUT DOWN. 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 21262086 ↗
• MalfunctionJan 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING USE ON A PATIENT, AFTER ANESTHESIA INDUCTION, BOTH THE MANUAL AND MACHINE CONTROLLED MODES OF VENTILATION FAILED TO FUNCTION, PREVENTING THE ANESTHESIA FROM PROCEEDING AS PLANNED. THE ANESTHESIA DEVICE WAS REPLACED BY A BACK-UP MACHINE - NO INJURY OR SERIOUS IMPAIRMENT OF PATIENT'S STATE OF HEALTH WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21227311 ↗
• MalfunctionJan 17, 2025Degraded; Failure to Deliver; No Pressure; Degraded; Failure to Deliver; No Pressure

  IT WAS REPORTED THAT THE DEVICE SUDDENLY ALARMED DURING A SURGICAL PROCEDURE AND SHUT DOWN AUTOMATIC VENTILATION. AS PER REPORT, THE DEVICE WAS REPLACED. THE EVENT DID NOT LEAD TO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21176423 ↗
• MalfunctionJan 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE SUDDENLY POSTED A "VENTILATOR FAILURE" ALARM DURING A RUNNING SURGERY AND THAT AUTOMATIC VENTILATION WAS SHUT DOWN. 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 21157027 ↗
• MalfunctionJan 13, 2025Degraded; Failure to Deliver; No Pressure; Degraded; Failure to Deliver; No Pressure

  THE FOLLOWING WAS REPORTED TO DRÄGER: "DURING GENERAL ANESTHESIA, IT WAS OBSERVED THAT THE VENTILATOR BELLOWS WERE NOT FUNCTIONING. AFTER SWITCHING TO MANUAL CONTROL, THE BELLOWS STILL DID NOT OPERATE. AFTER POWERING OFF AND RESTARTING THE DEVICE, IT BACKED TO NORMAL USE. NO ALARMS WERE TRIGGERED BY THE DEVICE THROUGHOUT THE ENTIRE PROCESS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21135546 ↗
• MalfunctionJan 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AUTOMATIC VENTILATION FAILED DURING A SURGICAL PROCEDURE. AS PER REPORT, THE USERS WERE AT FIRST UNABLE TO USE THE DEVICE IN MANUAL VENTILATION MODE AND WERE BRIDGING PATIENT SUPPORT WITH AN AMBU BAG. AFTER SEVERAL CHANGES BETWEEN AUTOMATIC AND MANUAL VENTILATION, THE PROCEDURE COULD REPORTEDLY BE FINISHED IN MANUAL VENTILATION. THE EVENT DID NOT LEAD TO CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21077156 ↗
• MalfunctionJan 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE ANESTHESIA WORKSTATION "SUDDENLY STOPPED WORKING" DURING A SURGICAL PROCEDURE. AS PER REPORT, THE DEVICE WAS REPLACED, AND NO CONSEQUENCES FOR THE PATIENT HAVE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21077051 ↗