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

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00855573007211), received between Aug 30, 2019 and Sep 27, 2026 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Output Problem” (32 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50910489 ↗
• MalfunctionMar 6, 2026Unexpected Shutdown

  AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE HAD "STOPPED WORKING" DURING USE. VENTEC ATTEMPTED TO GET CLARIFICATION OF HOW IT STOPPED WORKING, BUT WAS UNSUCCESSFUL. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24539166 ↗
• MalfunctionOct 20, 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 23343937 ↗
• MalfunctionOct 16, 2025Output Problem; Output Problem

  AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE WAS DELIVERING LOW INSPIRATORY PRESSURE. 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 OR THE EVENT WERE PROVIDED. VENTEC HAS REQUESTED ADDITIONAL INFORMATION ABOUT THE PATIENT, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316423 ↗
• MalfunctionJul 30, 2025Device Alarm System; Device Alarm System

  AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE'S ALARM WAS NOT WORKING AS EXPECTED (NO AUDIBLE ALARM). THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22671517 ↗
• MalfunctionJul 28, 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 INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22636742 ↗
• MalfunctionJul 15, 2025Output 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 22515937 ↗
• MalfunctionApr 18, 2025Output Problem; Output Problem

  AN AUTHORIZED SERVICE PROVIDER (ASP), CONTACTED VENTEC TO REPORT THAT THE DEVICE WAS PROVIDING INACCURATE 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 21867229 ↗
• MalfunctionApr 18, 2025Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21867106 ↗
• MalfunctionJan 13, 2025No Display/Image; No Display/Image

  IT WAS REPORTED TO VENTEC THAT THE DEVICE'S LCD DISPLAY TURNED BLACK DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. NO FURTHER DETAILS WERE PROVIDED. VENTEC REACHED OUT TO THE REPORTER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT, HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21140224 ↗
• MalfunctionJan 6, 2025Output Problem; Output Problem

  AN AUTHORIZED THIRD PARTY 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 21087990 ↗
• MalfunctionJan 2, 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 21061547 ↗
• MalfunctionDec 11, 2024Output Problem; Output Problem

  AN AUTHORIZED SERVICE PROVIDER (ASP), CONTACTED VENTEC TO REPORT THAT THE DEVICE WAS DELIVERING LOW VTE (EXHALED TIDAL VOLUME). THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20909548 ↗
• MalfunctionNov 18, 2024Output 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 20713679 ↗
• MalfunctionOct 24, 2024Output 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 20528050 ↗
• MalfunctionSep 25, 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 20306236 ↗
• MalfunctionSep 12, 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 20206658 ↗
• MalfunctionSep 10, 2024Output Problem; Output Problem

  AN AUTHORIZED THIRD PARTY SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE WAS PROVIDING AN ALARM INDICATING VERY 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 20185949 ↗
• MalfunctionJul 23, 2024Output 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 ITS INSPIRATORY PRESSURE WAS DROPPING IN BETWEEN BREATHS. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19813063 ↗
• MalfunctionJul 4, 2024Output Problem; Output Problem

  AN AUTHORIZED THIRD PARTY SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE HAD "FAILED" THE FIO2 (FRACTION OF INSPIRED OXYGEN) MONITORING PORTION OF THE PREVENTATIVE MAINTENANCE TESTING THEY WERE PERFORMING. NO FURTHER DETAILS WERE PROVIDED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19672932 ↗
• MalfunctionJun 19, 2024Output Problem; Output Problem

  AN AUTHORIZED THIRD PARTY 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 19571113 ↗
• MalfunctionMay 7, 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 19260744 ↗
• MalfunctionMar 14, 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 18905883 ↗
• MalfunctionMar 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. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18818722 ↗
• MalfunctionDec 8, 2023Output 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 18297619 ↗

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