Evita V600 8422300Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 04048675548744), received between Jul 26, 2022 and Aug 4, 2026 — classified as 1 death, 4 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (21 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2026Circuit Failure; Gas Output Problem; Failure to Deliver; Unexpected Shutdown

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50125605 ↗
• MalfunctionJun 23, 2026Insufficient Device Problem Information

  DRÄGER RECEIVED AN UFR WITH THE FOLLOWING STATEMENT: "DURING AN INSPECTION OF WHETHER THE INVASIVE VENTILATOR COULD FUNCTION PROPERLY, THE DEPARTMENT DISCOVERED THAT THE VENTILATOR AUTOMATICALLY RESTARTED AND WAS UNABLE TO PROVIDE NORMAL VENTILATION." IT WAS FURTHER MENTIONED THAT THE DEVICE WAS IMMEDIATELY REPLACED, PREVENTING FROM HEALTH CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25596823 ↗
• MalfunctionMar 25, 2026Display or Visual Feedback Problem; Image Display Error/Artifact; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE DISPLAY COULD NOT BE OPERATED DURING USE; THE SELECTED OPERATING SCREEN FLICKERED AND RESPONDED SLOWLY. THE DEVICE WAS SUBSEQUENTLY REPLACED AND FORWARDED TO DRÄGER SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686275 ↗
• MalfunctionMar 17, 2026No Display/Image; Display or Visual Feedback Problem; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE SCREEN WAS RESTARTED DURING CONNECTION TO THE PATIENT. THE VENTILATION WAS WORKING WITH NO STOP. NO PATIENT HEALTH CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616173 ↗
• MalfunctionMar 17, 2026Gas Output Problem; Decrease in Pressure; Failure to Sense; Failure to Deliver

  IT WAS REPORTED THAT THE DEVICE RESTARTED WHILE IN USE ON A PATIENT. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24616171 ↗
• MalfunctionJan 28, 2026Failure to Deliver; Complete Loss of Power; Unexpected Shutdown

  IT WAS REPORTED THAT THE DEVICE FAILED DURING ONGOING VENTILATION. THE DEVICE SOUNDED AN ALARM, AND VENTILATION WAS IMMEDIATELY RESUMED USING AN ALTERNATIVE VENTILATION METHOD. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24197530 ↗
• MalfunctionDec 2, 2025Gas Output Problem; Mechanical Problem; Failure to Deliver; Gas Output Problem; Mechanical Problem; Failure to Deliver

  IT WAS REPORTED THAT THE DEVICE DISPLAYED A "DEVICE FAILURE" DURING OPERATION. VENTILATION WAS NO LONGER POSSIBLE. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23690341 ↗
• MalfunctionDec 1, 2025Gas Output Problem; Mechanical Problem; Failure to Deliver; Gas Output Problem; Mechanical Problem; Failure to Deliver

  IT WAS REPORTED THAT THE DEVICE DISPLAYED A "DEVICE FAILURE" DURING OPERATION. VENTILATION WAS NO LONGER POSSIBLE. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23678892 ↗
• MalfunctionNov 24, 2025Gas Output Problem; Decrease in Pressure; Intermittent Communication Failure; Gas Output Problem; Decrease in Pressure; Intermittent Communication Failure

  IT WAS REPORTED THAT THE DEVICE WHILE OPERATED IN O2 THERAPY MODE ALERTED LOUDLY AND SHRILLY SEVERAL TIMES WITHIN AN HOUR, THEN SHUT DOWN AND REBOOTED. THERE WERE NO PATIENT HEALTH CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23629706 ↗
• MalfunctionOct 24, 2025No Display/Image; Failure to Deliver; Complete Loss of Power; Unexpected Shutdown; No Display/Image; Failure to Deliver; Complete Loss of Power; Unexpected Shutdown

  IT WAS REPORTED THAT THE ECD DISPLAY FAILED DURING OPERATION, AND THE DEVICE EMITTED A CONTINUOUS ALARM. VENTILATION CONTINUED. THE DEVICE WAS SUBSEQUENTLY REPLACED. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23377662 ↗
• MalfunctionAug 13, 2025No Display/Image; Device Difficult to Program or Calibrate; Failure to Deliver; No Display/Image; Device Difficult to Program or Calibrate; Failure to Deliver

  IT WAS REPORTED THAT A FAILURE OCCURRED DURING USE. THE DISPLAY OF THE DEVICE WENT BLACK, AND A CONTINUOUS AUDIBLE ALARM SOUNDED. THE ALARM COULD NOT BE PAUSED OR CANCELLED AND COULD ONLY BE STOPPED BY SWITCHING OFF THE DEVICE AT THE MAIN SWITCH. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22791869 ↗
• MalfunctionJul 21, 2025Gas Output Problem; Failure to Deliver; Physical Resistance/Sticking; Gas Output Problem; Failure to Deliver; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DEVICE STOPPED VENTILATING DURING USE AND ISSUED A DEVICE FAILURE ALARM. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554892 ↗
• InjuryJul 9, 2025No Display/Image; Device Difficult to Program or Calibrate; Failure to Deliver; No Display/Image; Device Difficult to Program or Calibrate; Failure to Deliver

  IT WAS REPORTED THAT AT AROUND 09:35 AM THE VENTILATOR HAD STOPPED VENTILATING, AND THE SCREEN HAD GONE BLANK. IT WAS REPORTED THAT THE PATIENT SUFFERED A BRIEF ASYSTOLE. THERE WAS NO PERMANENT DAMAGE TO THE PATIENT.

  Patient problems: Asystole

  MAUDE report 22456229 ↗
• InjuryJul 9, 2025Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT AT AROUND 11 PM THE VENTILATOR HAD A TOTAL FAILURE DURING OPERATION AND WITHOUT PRIOR NOTICE. IT WAS REPORTED THAT THE PATIENT HAD SUFFERED A HYPOXIC-INDUCED BRADYCARDIA AND A BRIEF ASYSTOLE. THE CONDITION WAS STABILIZED UNDER MANUAL VENTILATION. THE DEVICE WAS REPLACED WITH AN ANOTHER DEVICE.

  Patient problems: Asystole; Bradycardia; Hypoxia

  MAUDE report 22456228 ↗
• MalfunctionJun 6, 2025Decrease in Pressure; Inaccurate Delivery; Decrease in Pressure; Inaccurate Delivery

  IT WAS REPORTED THAT THE SCREEN OF THE DEVICE FROZE AND THEN THE DEVICE TURNED OFF DURING USE ON A PATIENT. AS A RESULT, THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157163 ↗
• MalfunctionApr 3, 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, THE PIEZO ALARM WAS GENERATED, AND THE VENTILATION STOPPED. THE DEVICE WAS REPLACED AND THE PATIENT WAS MANUALLY VENTILATED. THERE WAS NO SERIOUS INJURY REPORTED.

  Patient problems: Low Oxygen Saturation

  MAUDE report 21760154 ↗
• MalfunctionJan 17, 2025No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE DEVICE HAD A BLACK SCREEN DURING OPERATION WHEN SWITCHING FROM CPAP TO BIPAP. THE DEVICE WAS REPLACED IMMEDIATELY BY THE USER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21176436 ↗
• MalfunctionNov 8, 2024No Display/Image; Failure to Read Input Signal; No Display/Image; Failure to Read Input Signal

  IT WAS REPORTED THAT THE DEVICE'S SCREEN FAILED DURING TREATMENT OF A PATIENT WITH O2 THERAPY, CAUSING THE PIEZO ALARM TO BE TRIGGERED. VENTILATION CONTINUED AND THE PATIENT'S VITAL PARAMETERS WERE NOT AFFECTED. THE DEVICE WAS SUBSEQUENTLY REPLACED BY THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20639100 ↗
• MalfunctionJul 10, 2024Failure to Deliver; Complete Loss of Power; Unexpected Shutdown; Failure to Deliver; Complete Loss of Power; Unexpected Shutdown

  IT WAS REPORTED THAT THE DEVICE TURNED OFF DURING OPERATION, THE SCREEN WENT BLACK, THE PATIENT WAS NO LONGER VENTILATED AND AN AUDIBLE ALARM WAS GIVEN. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED. AT THE PRESENT TIME, A DEVICE MALFUNCTION CANNOT BE EXCLUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19708815 ↗
• MalfunctionJun 19, 2024Gas 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 WHEN IT WAS CONNECTED TO A PATIENT. THE DEVICE CONTINUED TO WORK ON THE PATIENT UNTIL IT WAS REPLACED. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564685 ↗
• MalfunctionJan 19, 2024Gas Output Problem; Decrease in Pressure; Reset Problem; Gas Output Problem; Decrease in Pressure; Reset Problem

  IT WAS REPORTED THAT THE EVITA V600 RESTARTED AUTOMATICALLY DURING VENTILATION OF THE PATIENT. THE DEVICE EMITTED AN AUDIBLE ALARM. IT WAS REPORTED THAT AN INTERNAL COMMUNICATION ERROR WAS DISPLAYED DURING START-UP. VENTILATION WAS THEN CONTINUED WITH THE LAST SETTINGS. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18541051 ↗
• InjuryAug 16, 2023Inaccurate Flow Rate; Gas Output Problem; Failure to Deliver; Inaccurate Flow Rate; Gas Output Problem; Failure to Deliver

  IT WAS REPORTED IN THE USER FACILITY REPORT: ¿THE PATIENT IS IN VC-AC, COUGHING, AND THE NURSE PERFORMS TRACHEAL SUCTIONING. WHEN SHE REMOVED THE SUCTION CATHETER AND CLOSED THE INTUBATION VALVE, SHE REALIZED THAT THE PATIENT WAS NO LONGER BREATHING, THE VENTILATOR WAS NOT BEEPING, VM 0, NO MORE CURVES AND A SLIGHT SOUND OF LEAKS AT EACH CYCLE. SHE QUICKLY CHECKED THE CONNECTIONS, THE CIRCUIT, NO LEAKS, STILL NO VENTILATION. CARDIOPULMONARY ARREST ALMOST IMMEDIATELY WHEN O2 SATURATION WAS AROUND 90%. ATTEMPT TO SET FI02 TO 100% ON THE VENTILATOR, THE SELECTION WORKS UP TO NUMBER 100 BUT IS NOT VALIDATED WHEN THE THUMBWHEEL IS PRESSED. CARDIOPULMONARY RESUSCITATION LASTING APPROXIMATELY 50 SECONDS WITH RESUMPTION WITH SELF-INFLATING BAGS, RESUMPTION OF HEART RHYTHM, ATTEMPT TO RECONNECT TO VENTILATOR, FAILURE, 2ND CARDIOPULMONARY ARREST, CARDIOPULMONARY RESUSCITATION LASTING APPROXIMATELY 40 SECONDS. RESUMPTION OF CARDIAC RHYTHM AND CONNECTION TO TRANSPORT VENTILATOR. PATIENT STABILIZED.¿

  Patient problems: Cardiac Arrest; Respiratory Arrest

  MAUDE report 17555309 ↗
• MalfunctionAug 7, 2023Gas 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 BEEPED BRIEFLY DURING OPERATION. AFTER THAT, THE DISPLAY FAILED. IT WAS NOT KNOWN FROM THE USER WHETHER THE VENTILATION STOPPED. THE DEVICE HAVE REBOOTED AFTERWARDS. IT WAS THEN TAKEN OUT OF OPERATION. NO PATIENT HEALTH CONSEQUENCES HAVE BEEN REPORTED. IN CASE THE BREATHING PRESSURE (INCL. PEEP) DROPS TO AMBIENT, A DETERIORATION IN STATE OF HEALTH CANNOT BE EXCLUDED FOR PATIENTS WITH DIFFICULT LUNG/VENTILATION CONDITIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17468495 ↗
• DeathJul 27, 2023Failure to Deliver; Adverse Event Without Identified Device or Use Problem; Failure to Deliver; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE AFFECTED DEVICE WAS USED IN A VOLUME-CONTROLLED VENTILATION MODE DURING RESUSCITATION OF A PATIENT. IT WAS FURTHER REPORTED THAT DURING THIS USE, THE DEVICE STOPPED VENTILATING WITH AN OVERPRESSURE ERROR. AS A RESULT, THE DEVICE WAS SWITCHED TO MANUAL VENTILATION. NO BLOCKAGE OF THE PATIENT'S AIRWAY WAS DETECTED DURING MANUAL VENTILATION. THE PATIENT PASSED AWAY. IT WAS FURTHER REPORTED THAT THE SELF-TEST AND THE BREATHING TUBE TEST OF THE DEVICE WERE SUCCESSFUL.

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

  MAUDE report 17404294 ↗
• MalfunctionJun 16, 2023Failure to Deliver; Complete Loss of Power; Unexpected Shutdown; Failure to Deliver; Complete Loss of Power; Unexpected Shutdown

  IT WAS REPORTED THAT THE DEVICE STOPPED WORKING WHILE IN USE AND SHOWED A BLACK SCREEN. ACCORDING TO THE USER, THE DEVICE GAVE AN ALARM HERE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17142618 ↗