Evita V800 8422500Recalls & reported problems

Summary

The FDA's MAUDE database contains 66 adverse event reports that list this exact device (DI 04048675542148), received between Jun 21, 2022 and Sep 29, 2026 — classified as 5 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (33 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 66 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Failure to Deliver

  It was reported that the device restarted whilst in use on a patient. No health consequences for the patient were reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930258 ↗
• MalfunctionMay 11, 2026Erratic or Intermittent Display; No Display/Image; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE SCREEN OF THE DEVICE WOULD KEEP FREEZING WHILE ON A PATIENT. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25134648 ↗
• MalfunctionMay 5, 2026Image Display Error/Artifact; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE SCREEN TURNED OFF MOMENTARILY ON A PATIENT WHILE THE UNIT WAS STILL VENTILATING. DISCUSSIO WITH AN RT. HE SAID : THE SCREEN WAS BLACK FOR PROBABLY MORE THAN 1 MINUTE AND CAME BACK BY ITSELF. NO HARM TO THE PATIENT . HE TESTED THE UNIT SEVERAL TIME AFTER AND NO OTHER ISSUE SHOWED UP. IN CASE THE USER CANNOT ADAPT VENTILATION PARAMETERS DUE TO A DEVICE MALFUNCTION FOR A PROLONGED TIME, A SERIOUS INJURY CANNOT BE EXCLUDED FOR PATIENTS WITH A SERIOUS CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25078177 ↗
• MalfunctionMar 30, 2026Failure to Deliver

  IT WAS REPORTED THAT THE DEVICE ISSUED A TEMPERATURE ALARM BEFORE THE DEVICE TURNED ITSELF OFF. THE DEVICE WAS REPLACED. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24726264 ↗
• InjuryMar 23, 2026Use of Device Problem; Unintended Electrical Shock

  IT WAS REPORTED THAT A RT GOT SHOCKED. CUSTOMER IS ALLEGING A DEVICE MALFUNCTION IN THIS INCIDENT. AFTER THE ELECTRIC SHOCK, THE NURSE PAIN FROM HER RIGHT FINGERS, UP HER ARM, AND THROUGH HER HEAD AND NECK. SHE WAS SENT HOME FROM THAT SHIFT.

  Patient problems: Headache

  MAUDE report 24661664 ↗
• MalfunctionMar 12, 2026Gas Output Problem; No Device Output; Failure to Deliver; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DEVICE STOPPED WORKING DURING USE. A DISCONNECTION/LEAKAGE WAS DETECTED WHILE A PATIENT WAS CONNECTED. THE SELF-TEST WAS INCOMPLETE. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586258 ↗
• MalfunctionMar 10, 2026No Display/Image; Device Difficult to Program or Calibrate

  WHILST ON A PATIENT, THE SCREEN BLACKED OUT AND DIDN¿T REBOOT. THE VENT WAS STILL VENTILATING AND PATIENT WAS NOT COMPROMISED. VENT SWAPPED OUT AND ISOLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24556176 ↗
• MalfunctionMar 9, 2026Decrease in Pressure; Failure to Deliver; Improper Flow or Infusion; Imprecise or Erratic Results

  IT WAS REPORTED THAT AT AROUND 06:18, THE WAVEFORM SUDDENLY DISAPPEARED. THE DEVICE WAS REPLACED. THE USER ATTACHED A TEST LUNG TO THE AFFECTED DEVICE AND ATTEMPTED VENTILATION, BUT VENTILATION COULD NOT BE ACHIEVED. WHEN ME COLLECTED THE EVENT LOG, NEGATIVE PRESSURE WAS OBSERVED. NO PATIENT HEALTH CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543336 ↗
• MalfunctionMar 5, 2026No Display/Image; Device Difficult to Program or Calibrate

  It was reported that the screen of the device blacked out and did not reboot. Reportedly, the ventilation was continued. The device was replaced. There were no health consequences for the patient reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24516667 ↗
• MalfunctionMar 4, 2026Delayed Alarm

  IT WAS REPORTED THAT THE DEVICE DID NOT DETECT THE DISCONNECTION FROM THE PATIENT TWICE. REPORTEDLY, IT TOOK ABOUT 20 SECONDS BEFORE IT ALARMED THAT THE PATIENT HAD BEEN DISCONNECTED. IT WAS REPORTED THAT THE SECOND TIME, IT CHANGED ITSELF INTO THE SUCTION MANEUVRE. NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24510709 ↗
• MalfunctionFeb 25, 2026No Display/Image; Device Difficult to Program or Calibrate; Output Problem

  IT WAS REPORTED THAT THE DEVICE STOPPED DURING USE. NO PATIENT HEALTH CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24441184 ↗
• MalfunctionFeb 9, 2026No Display/Image; Device Difficult to Program or Calibrate; No Flow

  IT WAS REPORTED THAT THE VENTILATOR SHUT DOWN WHILE IN USE ON A PATIENT AND CONTINUOUSLY ALARMED UNTIL THEY SWAPPED THEM TO A SPARE VENTILATOR. NO PATIENT HEALTH CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290263 ↗
• MalfunctionFeb 5, 2026Complete Loss of Power

  It was reported that the display of the unit went blank while the device was still ventilating. At a later point the device shut down by itself. No patient injury was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24266646 ↗
• MalfunctionJan 30, 2026Circuit Failure; Gas Output Problem; Failure to Deliver

  IT WAS REPORTED THAT THE VENTILATOR SHUT DOWN WITHOUT MANIPULATION AND RESTARTED WHILE THE PATIENT WAS BEING VENTILATED. EXACT INFORMATION ON WHETHER THE MONITOR FAILED IS STILL BEING CLARIFIED. THE NIGHT SHIFT REPORTED THAT THE PATIENT WAS VENTILATED WITH A BREATHING BAG. NO HEALTH CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24219905 ↗
• MalfunctionJan 19, 2026Image Display Error/Artifact; Device Difficult to Program or Calibrate; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DISPLAY FROZE; USER COULD NOT MAKE CHANGES. NO PATIENT HEALTH CONSEQUENCES HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24109022 ↗
• MalfunctionNov 26, 2025No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE DEVICE SWITCH OFF DURING VENTILATION WITH A LOUD, CONTINUOUS ALARM SOUND. NO PATIENT HEALTH CONSEQUENCES WERE REPORTED. THE SYSTEM TEST ON THE PREVIOUS DAY HAD BEEN COMPLETED WITHOUT ANY DEVIATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23655515 ↗
• InjuryNov 24, 2025Use of Device Problem; Misassembly by Users; No Apparent Adverse Event; Misassembled During Installation; Use of Device Problem; Misassembly by Users; No Apparent Adverse Event; Misassembled During Installation

  IT WAS REPORTED THAT THE VENTILATOR CIRCUIT HAD BEEN CONNECTED THE WRONG WAY ROUND DURING VENTILATION THERAPY, MEANING THE PATIENT MAY HAVE RECEIVED COLD, DRY AND INEFFECTIVE VENTILATION FOR UP TO 48 HOURS. DURING THIS TIME THE PATIENT NEEDED VERY HIGH PRESSURES, BECAME INCREASINGLY UNWELL, AND REQUIRED TWO REINTUBATIONS. ONCE THE CIRCUIT WAS CORRECTED, THE PATIENT DETERIORATED RAPIDLY AND WENT INTO CARDIAC ARREST, NEEDING CHEST COMPRESSIONS AND THREE DOSES OF ADRENALINE. IT WAS REPORTED THAT THE VENTILATORS WERE RELABELLED, TRAINING MATERIALS AND VIDEOS WERE RE-ISSUED, AND STAFF WAS PROVIDED WITH REFRESHER TRAINING. REPORTEDLY, THE VENTILATOR¿S SYSTEM-CHECK PASSED EVEN THOUGH THE INSPIRATORY AND EXPIRATORY LIMBS WERE CONNECTED THE WRONG WAY ROUND AND THE TWO PORTS LOOK ALMOST IDENTICAL ¿ BOTH WHITE, SIMILAR SIZE, AND LABELLED ¿INSP¿ AND ¿EXP¿ IN SMALL WHITE TEXT ON A BLUE BACKGROUND.

  Patient problems: Cardiac Arrest

  MAUDE report 23630978 ↗
• MalfunctionOct 28, 2025No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE DEVICE SHUT DOWN DURING PATIENT USE. REPORTEDLY, THE PIEZO ALARM KEPT SOUNDING AND THE SCREEN REMAINED COMPLETELY BLACK. IT IS PRESUMED THAT THE VENTILATION HAD STOPPED. THERE WAS NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401432 ↗
• MalfunctionOct 28, 2025No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT DURING VENTILATION OF AN INTUBATED PATIENT, THE DEVICE SCREEN SUDDENLY TURNED OFF WITHOUT STOPPING VENTILATION. ACCESS TO SETTINGS AND ALARM DISPLAY WAS NO LONGER POSSIBLE. THERE WERE NO PATIENT HEALTH CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401425 ↗
• MalfunctionOct 8, 2025Gas Output Problem; Failure to Deliver; Loss of Data; Output Problem; No Apparent Adverse Event; Data Problem; Gas Output Problem; Failure to Deliver; Loss of Data; Output Problem; No Apparent Adverse Event; Data Problem

  IT WAS REPORTED THAT AN ALARM OCCURRED WHILE IN USE OF PATIENT. THE MESSAGE "DATA HAS BEEN CORRUPTED" WAS DISPLAYED AND THE DEVICE STOPPED WORKING. A BLACKOUT OCCURRED. NO PATIENT HEALTH CONSEQUENCES HAVE BEEN REPORTED. AFTER CLOSURE OF THE CASE, AN ADDITIONAL INVESTIGATION WAS CONDUCTED. THE ADDITIONAL INVESTIGATION FOUND THE FOLLOWING RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23243061 ↗
• InjuryOct 1, 2025Unexpected Therapeutic Results; Inaccurate Delivery; High Readings; Unexpected Therapeutic Results; Inaccurate Delivery; High Readings

  IT WAS REPORTED THAT AN UNEXPECTED AUTO-TRIGGERING OF THE DEVICE OCCURRED WITH AN INVASIVELY VENTILATED PATIENT IN NEO MODE. WITH A SET RESPIRATORY RATE OF 18, THE PATIENT'S RESPIRATORY RATE INCREASED TO FREQUENCIES ABOVE 60 DESPITE DEEP SEDATION. REPORTEDLY, THERE WAS NO ALARM ON THE DEVICE. THIS BEHAVIOR LED TO A SIGNIFICANT DETERIORATION IN THE PATIENT'S CONDITION. THE NEOFLOW SENSOR WAS REPLACED. THE PROBLEM THEN NO LONGER OCCURRED. MEDICATION WAS ADMINISTERED TO STABILIZE THE PATIENT.

  Patient problems: Increased Respiratory Rate

  MAUDE report 23189927 ↗
• MalfunctionJul 29, 2025No Display/Image; Gas Output Problem; Decrease in Pressure; Intermittent Communication Failure; No Display/Image; Gas Output Problem; Decrease in Pressure; Intermittent Communication Failure

  IT WAS REPORTED WHERE A V800 VENTILATOR DISPLAY TURNED OFF ON A PATIENT DURING VENTILATION. THE PATIENT ON THE VENTILATOR CONTINUED TO RECEIVE BREATHS AND PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22641056 ↗
• MalfunctionJul 17, 2025Gas Output Problem; Decrease in Pressure; Failure to Sense; Failure to Deliver; Gas Output Problem; Decrease in Pressure; Failure to Sense; Failure to Deliver

  IT WAS REPORTED THAT THE DEVICE SWITCHED OFF WITHOUT ANY NOTIFICATION DURING USE. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22528545 ↗
• MalfunctionJul 15, 2025Gas Output Problem; Decrease in Pressure; Failure to Sense; Failure to Deliver; Gas Output Problem; Decrease in Pressure; Failure to Sense; Failure to Deliver

  IT WAS REPORTED THAT THE DEVICE HAD FAILED DURING OPERATION AND ALARMED A DEVICE FAILURE. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22505514 ↗
• MalfunctionJun 13, 2025No Display/Image; Device Difficult to Program or Calibrate; No Display/Image; Device Difficult to Program or Calibrate

  IT WAS REPORTED THAT THE SCREEN WENT BLANK DURING USE AND THE USER WAS UNSURE IF THE DEVICE CONTINUED TO OPERATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201211 ↗