VOCSN V+C, JapaneseRecalls & reported problems
Ventec Life Systems, Inc. · V+C, Japanese: The VOCSN Unified Respiratory System is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. It may be used in invasive and non- invasive applications. The VOCSN is intended for pediatric through adult patients weighing at least 5 kg. It is intended for use in home, hospital, institutional and transport settings, including portable applications. The integral cough assist option is intended for patients who are additionally unable to cough or clear secretions effectively. www.VentecLife.com · Class 2
All models of VOCSN (17)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Ventec VOCSN ventilator provides continuous breathing support at home, in hospital, and while transporting patients of all sizes. The 29 reports mostly describe the machine not delivering the pressure or breath volume it was set to, sometimes powering off or rebooting on its own and showing a circuit disconnect alarm. No deaths or injuries are reported, and none of the reports describe a problem in a patient. There are no recalls naming this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00850018761116), received between Jan 10, 2023 and Sep 27, 2026 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Output Problem” (26 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.
Reports received per month
Most reported problems
Device problems
- Output Problem26
- Unexpected Shutdown4
- No Display/Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions30
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2026Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910491 ↗MalfunctionMay 8, 2026Output Problem
AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE WAS PROVIDING AN ALARM INDICATING LOW INSPIRATORY PRESSURE AND DELIVERING LOW VTE (EXHALED TIDAL VOLUME) LEVELS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25128824 ↗MalfunctionMar 30, 2026Unexpected 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 24727291 ↗MalfunctionDec 19, 2025Output Problem; Output Problem
AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE WAS DISPLAYING THE PATIENT CIRCUIT DISCONNECT ALARM. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23858167 ↗MalfunctionNov 18, 2025Output Problem; Output Problem
AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE VENTILATOR MEASURED LOWER PEEP (POSITIVE END EXPIRATORY PRESSURE) THAN SET AND 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 23589169 ↗MalfunctionOct 30, 2025Output Problem; Output Problem
AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE WAS DELIVERING LOWER THAN 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 23428167 ↗MalfunctionSep 17, 2025Output Problem; Output Problem
AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE WAS DELIVERING LOWER THAN SET PEEP (POSITIVE END EXPIRATORY PRESSURE) AND LOW VTE (EXHALED TIDAL VOLUME). THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23078442 ↗MalfunctionJul 17, 2025No Display/Image; Unexpected Shutdown; No Display/Image; Unexpected Shutdown
AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE HAD POWERED OFF UNEXPECTEDLY. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22535948 ↗MalfunctionJul 11, 2025Output Problem; Output Problem
AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE WAS DISPLAYING THE PATIENT CIRCUIT DISCONNECT ALARM. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22486767 ↗MalfunctionMay 5, 2025Output Problem; Output Problem
AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE HAD NO VENTILATION OUTPUT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21964110 ↗MalfunctionMar 13, 2025Output Problem; Output Problem
AN AUTHORIZED SERVICE PROVIDER (ASP), CONTACTED VENTEC TO REPORT THAT THE VENTILATOR PROVIDED AN ALARM INDICATING LOWER PEEP (POSITIVE END EXPIRATORY PRESSURE) THAN SET. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21602193 ↗MalfunctionMar 10, 2025Output Problem; Output Problem
AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE WAS DELIVERING LOWER THAN SET PEEP (POSITIVE END EXPIRATORY PRESSURE) AND LOW VTE (EXHALED TIDAL VOLUME). THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21568921 ↗MalfunctionMar 7, 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 21554329 ↗MalfunctionAug 22, 2024Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED TO VENTEC BY AN AUTHORIZED THIRD PARTY SERVICE PROVIDER (ASP) THAT THE DEVICE WAS REBOOTING BY ITSELF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20027101 ↗MalfunctionJul 10, 2024Output Problem; Output Problem
AN AUTHORIZED THIRD PARTY SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE WAS UNABLE TO MAINTAIN PEEP (POSITIVE END EXPIRATORY PRESSURE). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19716579 ↗MalfunctionJul 8, 2024Unexpected Shutdown; Unexpected Shutdown
AN AUTHORIZED THIRD PARTY SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE ALLEGEDLY BEGAN REBOOTING BY ITSELF 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. NO FURTHER DETAILS ABOUT THE PATIENT WERE PROVIDED. VENTEC HAS REACHED OUT TO THE ASP IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT, BUT NO RESPONSE HAS BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19698028 ↗MalfunctionApr 8, 2024Output Problem; Output Problem
AN AUTHORIZED THIRD PARTY SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE VENTILATOR MEASURED LOWER PEEP (POSITIVE END EXPIRATORY PRESSURE) THAN SET. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19066815 ↗MalfunctionApr 1, 2024Output Problem; Output Problem
AN AUTHORIZED THIRD PARTY SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE VENTILATOR MEASURED LOWER PEEP (POSITIVE END EXPIRATORY PRESSURE) THAN SET AND 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 19015981 ↗MalfunctionApr 1, 2024Output Problem; Output Problem
AN AUTHORIZED THIRD PARTY SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE VENTILATOR MEASURED LOWER PEEP (POSITIVE END EXPIRATORY PRESSURE) THAN SET AND 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 19015668 ↗MalfunctionMar 29, 2024Output Problem; Output Problem
AN AUTHORIZED THIRD PARTY SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE VENTILATOR MEASURED LOWER PEEP (POSITIVE END EXPIRATORY PRESSURE) THAN SET. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19008951 ↗MalfunctionMar 13, 2024Output Problem; Output Problem
AN AUTHORIZED THIRD PARTY SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE VENTILATOR MEASURED LOWER PEEP (POSITIVE END EXPIRATORY PRESSURE) THAN SET. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18896490 ↗MalfunctionFeb 20, 2024Output Problem; Output Problem
AN AUTHORIZED THIRD PARTY SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE VENTILATOR MEASURED LOWER PEEP (POSITIVE END EXPIRATORY PRESSURE) THAN SET. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18744586 ↗MalfunctionFeb 2, 2024Output Problem; Output Problem
AN AUTHORIZED THIRD PARTY SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE'S 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 18632106 ↗MalfunctionDec 8, 2023Output Problem; Output Problem
AN AUTHORIZED THIRD PARTY SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE VENTILATOR MEASURED LOWER PEEP (POSITIVE END EXPIRATORY PRESSURE) THAN SET. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18294827 ↗MalfunctionNov 16, 2023Output Problem; Output Problem
AN AUTHORIZED THIRD PARTY SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE VENTILATOR MEASURED LOWER PEEP (POSITIVE END EXPIRATORY PRESSURE) THAN SET. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18150276 ↗
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, ClassifiedVOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
- Z-1942-2026 · Mar 25, 2026 · Open, ClassifiedVOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
- Z-1196-2025 · Feb 3, 2025 · Open, ClassifiedVOCSN 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, ClassifiedVOCSN 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, ClassifiedVentec 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
Other Ventilator, Continuous, Facility Use devices
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USARespironics, Inc. · Ventilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USARespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- CARESCAPE R860Datex-Ohmeda Inc · VENTILATOR, CONTINUOUS, FACILITY USE1 recall1 death4,346 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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