VOCSN V+C+Pro, Japanese (REF PRT-00900-100)Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 00855573007785), received between Feb 9, 2023 and Jun 30, 2026 — classified as 33 malfunctions.

The most frequently reported specific device problem is “Output Problem” (29 reports).

1 FDA recall record name this device's identifier, 1 still open.

4 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.

Recalls naming this device

1. May 10, 2021Class IIOpen, Classified

   Due to a component failure, ventilators may unexpectedly shut down or have a loss of blower function while in patient use. The shutdown potentially prevents the ventilator from providing ventilation therapy.

   Z-1902-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Output Problem

  AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE WAS DELIVERING LOW INSPIRATORY PRESSURE AND 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 25673746 ↗
• MalfunctionMay 8, 2026Output Problem

  AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE WAS PROVIDING LOW FIO2 (FRACTION OF INSPIRED OXYGEN) READINGS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25126444 ↗
• MalfunctionMar 3, 2026Output Problem

  AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE WAS PROVIDING LOW FIO2 (FRACTION OF INSPIRED OXYGEN) READINGS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501663 ↗
• MalfunctionFeb 16, 2026Output Problem

  AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE WAS DELIVERING LOWER THAN SET PEEP (POSITIVE END EXPIRATORY PRESSURE), LOW VTE (EXHALED TIDAL VOLUME), AND LOW INSPIRATORY PRESSURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24356897 ↗
• MalfunctionFeb 4, 2026Output Problem

  AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE WAS PROVIDING LOW FIO2 (FRACTION OF INSPIRED OXYGEN) READINGS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24264143 ↗
• MalfunctionDec 19, 2025Output Problem; Output Problem

  AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE'S EXHALED TIDAL VOLUME (VTE) LEVELS WERE LOW AND THAT THE DEVICE WAS DISPLAYING A LOW INSPIRATORY PRESSURE ALARM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23858158 ↗
• 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 23857629 ↗
• MalfunctionNov 24, 2025Output Problem; Output Problem

  AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE WAS PROVIDING LOW FIO2 (FRACTION OF INSPIRED OXYGEN) READINGS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23640560 ↗
• MalfunctionNov 18, 2025Output Problem; Output Problem

  AN AUTHORIZED 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 23589392 ↗
• MalfunctionNov 16, 2025Output Problem; Output Problem

  AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE 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 23565647 ↗
• MalfunctionOct 22, 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 23359895 ↗
• MalfunctionOct 17, 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 INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23331238 ↗
• MalfunctionAug 27, 2025Output Problem; Output Problem

  AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE'S EXHALED TIDAL VOLUME (VTE) LEVELS WERE LOW, AND THAT IT HAD DISPLAYED THE LOW INSPIRATORY PRESSURE ALARM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22905445 ↗
• MalfunctionAug 14, 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). IT WAS ALSO REPORTED THAT THE DEVICE HAD DISPLAYED THE LOW INSPIRATORY PRESSURE ALARM. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22812584 ↗
• MalfunctionAug 11, 2025Output Problem; Output Problem

  AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE WAS DISPLAYING THE HIGH PEEP (POSITIVE END EXPIRATORY PRESSURE) ALARM. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22773830 ↗
• MalfunctionJun 17, 2025Output 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), RESULTING IN LOWER PEEP THAN SET. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22248234 ↗
• MalfunctionJun 11, 2025Unexpected Shutdown; Unexpected Shutdown

  AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE HAD UNEXPECTEDLY POWERED OFF DURING USE. NO FURTHER DETAILS ABOUT THE PATIENT WERE AVAILABLE, HOWEVER, THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. THE ASP CONFIRMED THAT THE PATIENT SURVIVED THE REPORTED EVENT. FOLLOWING THE EVENT, THE ASP ADVISED THAT PERSONNEL OBSERVED THAT THE DEVICE BEGAN REBOOTING BY ITSELF WHILE SITTING AT A NURSES STATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22191146 ↗
• MalfunctionJun 9, 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 22172555 ↗
• MalfunctionMay 16, 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 22038257 ↗
• MalfunctionMar 28, 2025Output Problem; Output Problem

  AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE 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 21727236 ↗
• MalfunctionMar 27, 2025Output Problem; Output Problem

  AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE 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 21712977 ↗
• MalfunctionJan 22, 2025Output Problem; Output Problem

  AN AUTHORIZED THIRD-PARTY SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE VENTILATOR PROVIDED AN ALARM INDICATING HIGHER 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 21210914 ↗
• MalfunctionJan 20, 2025Output 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 21194154 ↗
• MalfunctionJan 15, 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). IT WAS ALSO REPORTED THAT THE DEVICE HAD DISPLAYED THE PATIENT CIRCUIT DISCONNECT ALARM. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21164242 ↗
• MalfunctionJul 22, 2024Connection Problem; Output Problem; Connection Problem; Output Problem

  AN AUTHORIZED THIRD PARTY SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REQUEST SERVICE FOR A DEVICE. THE ASP ADVISED THAT THE DEVICE HAD REPORTEDLY ALARMED CONTINUOUSLY DURING USE. THE ASP FURTHER ADVISED THAT THEY WERE UNABLE TO OBTAIN THE ALARM HISTORY OR REPRODUCE ANY ALARMS AND WERE REQUESTING THAT VENTEC PERFORM AN EVALUATION OF THE DEVICE. THE ASP ADVISED THAT THERE WAS NO PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. THE PATIENT WAS PLACED ON A BACKUP DEVICE FOR SUPPORT AND SURVIVED THE REPORTED EVENT. DURING THE DEVICE'S EVALUATION, VENTEC DOWNLOADED THE DEVICE'S SYSTEM LOGS FOR ANALYSIS. VENTEC OBSERVED THAT ON THE DATE OF THE EVENT, THE DEVICE HAD LOGGED PATIENT CIRCUIT DISCONNECT ALARMS IN ITS MEMORY. ADDITIONALLY, WHILE TESTING THE DEVICE VENTEC OBSERVED THAT IT ALARMED DUE TO LOW INSPIRATORY PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19797224 ↗

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