VOCSN V+C+S+N+Pro, EnglishRecalls & reported problems

Summary

The FDA's MAUDE database contains 185 adverse event reports that list this exact device (DI 00855573007860), received between Aug 4, 2022 and Jun 1, 2026 — classified as 3 injuries, 182 malfunctions.

The most frequently reported specific device problem is “Output Problem” (160 reports).

5 other recalls cover devices cleared under the same FDA submission (K162877); 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 185 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. DURING THE DEVICE EVALUATION, VENTEC OBSERVED THAT ITS EXHALED TIDAL VOLUME (VTE) LEVELS WERE LOW. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25351417 ↗
• MalfunctionMay 1, 2026Display or Visual Feedback Problem

  IT WAS REPORTED TO VENTEC THAT THE LCD TOUCHSCREEN ON THE DEVICE WAS CRACKED AND UNRESPONSIVE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25059154 ↗
• MalfunctionApr 29, 2026Unexpected Shutdown

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT WAS REBOOTING BY ITSELF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25038228 ↗
• MalfunctionApr 20, 2026Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE CONTINUOUSLY REBOOTS BY ITSELF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933653 ↗
• MalfunctionApr 16, 2026Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT WAS DELIVERING LOWER THAN SET PEEP (POSITIVE END EXPIRATORY PRESSURE). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24904755 ↗
• MalfunctionMar 18, 2026Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE WAS DELIVERING LOW VTE (EXHALED TIDAL VOLUME) AND THAT IT WAS "LEAKING OXYGEN". VENTEC HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE INITIAL REPORTER IN AN EFFORT TO OBTAIN CLARIFICATION ABOUT THE "LEAKING OXYGEN" ISSUE, BUT NO RESPONSE HAS BEEN RECEIVED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634123 ↗
• MalfunctionFeb 16, 2026Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT WAS DISPLAYING THE PATIENT CIRCUIT DISCONNECT ALARM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24355931 ↗
• MalfunctionFeb 4, 2026Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE CONTINUOUSLY REBOOTS BY ITSELF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24264395 ↗
• MalfunctionNov 24, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT PROVIDED AN ALARM INDICATING LOW INSPIRATORY PRESSURE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23640553 ↗
• MalfunctionNov 19, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT WAS DISPLAYING THE PATIENT CIRCUIT DISCONNECT ALARM. IT WAS ALSO OBSERVED THAT THE DEVICE WAS DELIVERING LOWER THAN SET PEEP (POSITIVE END EXPIRATORY PRESSURE). THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23598720 ↗
• MalfunctionNov 12, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT WAS REBOOTING BY ITSELF. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23539050 ↗
• MalfunctionNov 7, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT ITS LOW VTE (EXHALED TIDAL VOLUME) LEVELS WERE LOW. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23504040 ↗
• MalfunctionOct 20, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE UNEXPECTEDLY POWERED OFF DURING USE. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT; HOWEVER, THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. VENTEC HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23344155 ↗
• MalfunctionAug 8, 2025Output Problem; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE'S TIDAL VOLUME (VTE) LEVELS WERE LOW. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22754855 ↗
• MalfunctionAug 1, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, IT WAS OBSERVED THAT THE DEVICE HAD LOGGED AN ALARM INDICATING HIGHER PEEP (POSITIVE END EXPIRATORY PRESSURE) THAN SET. ADDITIONALLY, VENTEC OBSERVED THAT THE DEVICE WAS STRUGGLING TO MAINTAIN PEEP, RESULTING IN LOWER PEEP THAN SET. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22690605 ↗
• MalfunctionJul 11, 2025Output Problem; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE NEEDED SERVICE. DURING THE DEVICE'S EVALUATION, VENTEC OBSERVED THAT IT WAS PROVIDING LOW FIO2 (FRACTION OF INSPIRED OXYGEN) READINGS. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22487540 ↗
• MalfunctionJul 11, 2025Unexpected Shutdown; Unexpected Shutdown

  AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE WAS REBOOTING BY ITSELF. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22486916 ↗
• MalfunctionJun 30, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT WAS DEVICE WAS PROVIDING LOW FIO2 (FRACTION OF INSPIRED OXYGEN) LEVELS. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22368115 ↗
• InjuryJun 17, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO A VENTEC VENTILATION PRODUCT SUPPORT SPECIALIST THAT THE DEVICE ALARMED AND POWERED OFF BY ITSELF DURING USE. THE REPORTER ADVISED VENTEC THAT AFTER THE DEVICE POWERED OFF, THEY REMOVED THE PATIENT FROM THE VENTILATOR AND BEGAN TO PROVIDE MANUAL VENTILATION. THE VENTILATOR WAS THEN RESTARTED BUT POWERED OFF BY ITSELF AGAIN. THE REPORTER ADVISED THAT THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE, HOWEVER, THE INCIDENT NECESSITATED MEDICAL INTERVENTION IN ORDER TO PREVENT PERMANENT DAMAGE/IMPAIRMENT TO THE PATIENT (MANUAL VENTILATION). NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. VENTEC HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE REPORTER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT, HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22246142 ↗
• MalfunctionJun 17, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT WAS DELIVERING LOW FIO2 (FRACTION OF INSPIRED OXYGEN) LEVELS. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22244085 ↗
• MalfunctionJun 2, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. DURING EVALUATION VENTEC OBSERVED THAT THE DEVICE WAS MEASURING A LOW VTE (EXHALED TIDAL VOLUME) VALUE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22128633 ↗
• MalfunctionMay 8, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT THE DEVICE'S ALARMS WERE NOT WORKING AS EXPECTED. VENTEC OBSERVED THAT THE DEVICE'S ALARM SILENCE BUTTON WAS ACTIVATED UPON STARTUP, CAUSING THE DEVICE NOT TO PROVIDE AN AUDIBLE ALARM. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986679 ↗
• MalfunctionMay 8, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT ITS AUDIBLE ALARM WAS NOT FUNCTIONING AS EXPECTED. VENTEC OBSERVED THAT THE DEVICE'S "AUDIO PAUSE" FUNCTION SELF TRIGGERED MULTIPLE TIMES WITHOUT PRESSING THE BUTTON. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986621 ↗
• MalfunctionMay 6, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT THE VENTILATOR MEASURED LOWER PEEP (POSITIVE END EXPIRATORY PRESSURE) THAN SET AND THAT IT DISPLAYED A PATIENT CIRCUIT DISCONNECT ALARM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21973386 ↗
• MalfunctionApr 17, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT WAS UNABLE TO MAINTAIN SET PEEP (POSITIVE END EXPIRATORY PRESSURE). THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862662 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162877. One submission often covers many models, so check the product and lot details in each record.

• Z-2525-2026 · May 8, 2026 · Open, Classified
  VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
• Z-1942-2026 · Mar 25, 2026 · Open, Classified
  VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
• Z-1196-2025 · Feb 3, 2025 · Open, Classified
  VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002
• Z-1070-2024 · Jan 9, 2024 · Open, Classified
  VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides c
• Z-1902-2021 · May 10, 2021 · Open, Classified
  Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900