IACS Workstation Critical Care 8416400Recalls & reported problems

Summary

The FDA's MAUDE database contains 213 adverse event reports that list this exact device (DI 04048675042266), received between Nov 18, 2016 and Jul 15, 2026 — classified as 5 deaths, 14 injuries, 194 malfunctions.

The most frequently reported specific device problem is “Gas Output Problem” (85 reports).

1 FDA recall record name this device's identifier.

5 other recalls cover devices cleared under the same FDA submission (K093633); they may or may not involve this specific model.

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.

Recalls naming this device

1. Feb 14, 2022Class IITerminated

   Cybersecurity Improvement Action-not equipped against potential cyber security threats

   Z-0870-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 213 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2026Inaccurate Flow Rate; Gas Output Problem; Failure to Deliver; Difficult or Delayed Activation

  It was reported that the device made loud clicking noises during use. Values were not displayed on the screen. It was reported that device turned on and off and the patient was not ventilated. The device was eventually replaced. No health consequences for the patient were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25824509 ↗
• MalfunctionMay 13, 2026No Display/Image; Insufficient Device Problem Information

  THE FOLLOWING WAS REPORTED TO DRAEGER: "ON PATIENT SCREEN FROZE." NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25158792 ↗
• MalfunctionMay 13, 2026Gas Output Problem; Decrease in Pressure; Failure to Deliver; Intermittent Communication Failure

  IT WAS REPORTED THAT THE DEVICE HAD AN UNSPECIFIED ISSUE DURING PATIENT USE. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25158790 ↗
• MalfunctionApr 24, 2026No Display/Image

  IT WAS REPORTED THAT THE COCKPIT OF THE DEVICE PERFORMED A RESTART. THE ONGOING VENTILATION WAS NOT AFFECTED. NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24978999 ↗
• MalfunctionApr 23, 2026No Display/Image; Failure to Read Input Signal

  IT WAS REPORTED THAT THE DEVICE HAD FAILED DURING THE OPERATION ON THE PATIENT. VENTILATION CONTINUED. THE DEVICE WAS REPLACED. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24962549 ↗
• MalfunctionApr 22, 2026No Display/Image; Failure to Deliver

  IT WAS REPORTED THAT THE VENT WAS IN USE ON (B)(6) 2026, TIME UNKNOWN IN AC MODE. IT WAS IN USE FOR ABOUT 15 MINUTES THEN IT STOPPED THERAPY, RED ALARM DISPLAYED, AUDIBLE BEEP, VENT FAILURE ALARM DISPLAYED. THE RESPIRATORY THERAPIST USED TOGGLE SWITCH TO SHUT ALARM OFF. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954027 ↗
• MalfunctionFeb 27, 2026No Display/Image; Failure to Read Input Signal

  IT IS REPORTED THAT THE UNIT WAS ON A PATIENT TODAY, ON (B)(6) 2026 AND AT 3:00 AM THE UNIT DID A COCKPIT RESTART. NO REPORTED PATIENT INJURY. ONCE POWERED OFF IT HAS POWERED BACK UP. VENTILATION CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24468057 ↗
• MalfunctionFeb 19, 2026No Display/Image; Device Difficult to Program or Calibrate

  THE FOLLOWING WAS REPORTED TO DRAEGER - THE REPORTED ISSUE IS THAT ON FRIDAY (B)(6) 2026. IN THE MORNING WHILE ON A PATIENT THE UNIT SCREEN WENT BLACK. THE VENTILATOR STAYED RUNNING. THE SWAPPED THE VENTILATOR OUT. NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24385614 ↗
• MalfunctionDec 17, 2025Use of Device Problem; Failure to Deliver; Use of Device Problem; Failure to Deliver

  THE FOLLOWING WAS REPORTED: (B)(6) 2025 ~11:09:16~WHILE ON A PATIENT UNIT ALARMED "DEVICE FAILURE (1)" AND SHUTDOWN. THERAPIST WAS NEAR ROOM WHEN THE UNIT ALARMED AND SHUTDOWN. AT THE PRESENT TIME, A STOPP OF VENTILATION CANNOT BE EXCLUDED. NO PAT. HEALTH CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825711 ↗
• MalfunctionDec 17, 2025Gas Output Problem; Decrease in Pressure; Failure to Deliver; Intermittent Communication Failure; Gas Output Problem; Decrease in Pressure; Failure to Deliver; Intermittent Communication Failure

  THE FOLLOWING WAS REPORTED: SHUTDOWN ON PATIENT AND REBOOTED, WHEN IT CAME UP IT SHOWED "DEVICE FAILURE 1". EVENT OCCURRED (B)(6) 2025, TIME 13:00, NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825708 ↗
• MalfunctionDec 16, 2025Erratic or Intermittent Display; No Display/Image; Device Difficult to Program or Calibrate; Erratic or Intermittent Display; No Display/Image; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE DEVICE RESTARTED UNEXPECTEDLY WHEN IT WAS CONNECTED TO THE PATIENT, ON (B)(6) 2025 TIME OF INCIDENT 1100 AM. THE PATIENT EXPERIENCED BRIEF DESATURATION TO 83% HOWEVER NOT HARM, QUICKLY IMPROVED AFTER DISCONNECTION (PRIOR TO EVENT PATIENT ONLY ON FIO2 0.3, BUT IS PRESSURE SUPPORT DEPENDENT). NOTED ON VENTILATOR LOW O2 ALARM, NOT SURE IF THERE WAS ALSO " LOW FLOW" ALARM. THE PATIENT WAS DISCONNECTED FROM VENTILATOR, SATURATION IMMEDIATELY IMPROVED > 90%. THIS WAS A LONG-TERM ICU PATIENT, AND VENTILATOR IN USE FOR LONG.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23813938 ↗
• MalfunctionNov 18, 2025No Display/Image; Failure to Read Input Signal; Failure to Deliver; No Display/Image; Failure to Read Input Signal; Failure to Deliver

  IT WAS REPORTED THAT THE DEVICE IS STOPPED DURING VENTILATION AND HAS REBOOTED REPEATEDLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23580965 ↗
• MalfunctionNov 12, 2025Gas Output Problem; Decrease in Pressure; Intermittent Communication Failure; Gas Output Problem; Decrease in Pressure; Intermittent Communication Failure

  IT WAS REPORTED THAT THE AFFECTED DEVICE HAD PERFORMED A RESTART WHILE USED ON A PATIENT. THERE WERE NO PATIENT HEALTH CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23530140 ↗
• MalfunctionOct 27, 2025No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE SCREEN OF THE AFFECTED DEVICE HAD GONE BLANK WHILE IT WAS ON A PATIENT. THE VENTILATOR CONTINUED TO VENTILATE. NO PATIENT HEALTH CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23389163 ↗
• MalfunctionOct 8, 2025Improper Flow or Infusion; Adverse Event Without Identified Device or Use Problem; Improper Flow or Infusion; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INTUBATED PT [PATIENT] ON VENTILATOR, NOT RECEIVING PROPER SUPPORT BASED ON SETTINGS (ALTERNATING TIDAL VOLUMES, PT TACHYPNEIC/IRREGULAR RESP. [RESPIRATORY] RATES). ADDITIONAL SEDATION WAS STARTED, TESTING DONE, VENT ALARMING CONTINUOUSLY D/T [DUE TO] DIFFERENT PARAMETERS. RT [RESPIRATORY THERAPY], RN, MD & PA [PHYSICIAN ASSISTANT] ALL IN ROOM CONTINUOUSLY FREQUENTLY THROUGHOUT SHIFT. PARALYTIC DRUG ORDERED AND PUSHED AS CLINICALLY INDICATED, DID NOT ACHIEVE EXPECTED AFFECT AS PT WAS STILL TACHYPNEIC AND NOT RECEIVING ADEQUATE TIDAL VOLUMES. DECISION MADE WITH TEAM TO TRY SWITCHING TO A NEW VENTILATOR WITH MD, PA, RT, AND RN AT BEDSIDE. ONCE PT SWITCHED TO NEW VENTILATOR, THE ISSUE WAS COMPLETELY RESOLVED. PT WAS IN SYNCH WITH VENT SETTINGS AND NO LONGER TACHYPNEIC. NO PATIENT INJURY.

  Patient problems: Increased Respiratory Rate

  MAUDE report 23243739 ↗
• MalfunctionSep 15, 2025No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE DISPLAY IMAGE TURNED OFF DURING VENTILATION. DEVICE CONTINUED VENTILATING DESPITE NO IMAGE ON DISPLAY. NO INJURY WAS REPORTED.

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

  MAUDE report 23049494 ↗
• MalfunctionSep 12, 2025Gas Output Problem; Decrease in Pressure; Failure to Deliver; Reset Problem; Gas Output Problem; Decrease in Pressure; Failure to Deliver; Reset Problem

  IT WAS REPORTED THAT THE DEVICE RESTARTED SEVERAL TIMES DURING PATIENT USE. THERE WAS NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23035221 ↗
• MalfunctionSep 3, 2025No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THERE WAS A SCREEN MALFUNCTION NOTICED WHILE THE DEVICE WAS IN USE. THE SCREEN FIRST FLICKERED BETWEEN BLACK AND WHITE, AND THEN BLACKED OUT COMPLETELY. AFTER TURNING THE POWER ON AGAIN, THE SCREEN DID NOT COME BACK ON. REPORTEDLY, THE VENTILATION WAS WORKING. THERE WERE NO PATIENT HEALTH CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22951125 ↗
• MalfunctionSep 2, 2025Inaccurate Flow Rate; Gas Output Problem; Failure to Deliver; Inaccurate Flow Rate; Gas Output Problem; Failure to Deliver

  IT WAS REPORTED THAT THE DEVICE STOPPED THE VENTILATION WHEN THE NEBULIZER WAS ACTIVATED. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22932020 ↗
• MalfunctionJul 24, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE SCREEN OF THE DEVICE WENT BLACK WHILE BEING USED ON A PATIENT. THERE WAS NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22584937 ↗
• MalfunctionJul 7, 2025Gas Output Problem; Decrease in Pressure; Failure to Deliver; Intermittent Communication Failure; Gas Output Problem; Decrease in Pressure; Failure to Deliver; Intermittent Communication Failure

  IT WAS REPORTED THAT THE DEVICE ALARMED FOR A DEVICE FAILURE DURING USE ON A PATIENT. THE SOFT KEY BUTTONS WERE FROZEN ON THE SCREEN, AND THE DEVICE COULD NOT BE TURNED OFF. THE DEVICE WAS REPLACED. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22413068 ↗
• MalfunctionMay 23, 2025Use of Device Problem; Failure to Deliver; Use of Device Problem; Failure to Deliver

  DEVICE RESTARTED ON PATIENT. EVENT OCCURRED (B)(6) 2025 AT 06:57 CENTRAL, NO ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22076249 ↗
• MalfunctionMay 16, 2025Premature Discharge of Battery; Failure to Deliver; Complete Loss of Power; Premature Discharge of Battery; Failure to Deliver; Complete Loss of Power

  IT WAS REPORTED THAT DURING TRANSPORT THE VENTILATOR SHUTDOWN WITHOUT WARNING. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034271 ↗
• MalfunctionMay 8, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE DEVICE TURNED ITSELF OFF TWICE DURING PATIENT USE. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21983399 ↗
• MalfunctionApr 24, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE COCKPIT OF THE DEVICE RESTARTED DURING USE ON A PATIENT. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21897984 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093633. One submission often covers many models, so check the product and lot details in each record.

• Z-0108-2022 · Sep 10, 2021 · Open, Classified
  Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
• Z-0827-2016 · Feb 4, 2016 · Terminated
  Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
• Z-0436-2016 · Dec 1, 2015 · Terminated
  Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pedia
• Z-2343-2015 · Jul 13, 2015 · Terminated
  PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
• Z-1298-2014 · Feb 7, 2014 · Terminated
  Draeger PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500), Evita V500 and /or Babylog VN500 Ventilators, used for ventilation during shor