VOCSN V+Pro, English (REF PRT-01185-001)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00850018761161), received between Aug 4, 2023 and Nov 27, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Output Problem” (10 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 27, 2024Output 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 UNSTABLE (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 20793173 ↗
• MalfunctionNov 27, 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 20792947 ↗
• MalfunctionNov 27, 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 20792636 ↗
• MalfunctionNov 26, 2024Electrical /Electronic Property Problem; Failure to Power Up; Electrical /Electronic Property Problem; Failure to Power Up

  IT WAS REPORTED TO VENTEC BY AN AUTHORIZED THIRD-PARTY SERVICE PROVIDER (ASP) THAT THE DEVICE WAS INOPERATIVE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20782449 ↗
• MalfunctionNov 7, 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 20634474 ↗
• MalfunctionNov 6, 2024Output 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 20617073 ↗
• MalfunctionOct 10, 2024Output 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 AND WAS UNABLE TO MAINTAIN SET PEEP. IT WAS ALSO REPORTED THAT THE DEVICE WAS DELIVERING 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 20420844 ↗
• MalfunctionJun 19, 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 19571185 ↗
• MalfunctionJun 14, 2024Output Problem; Output 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 19542875 ↗
• MalfunctionAug 28, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE VENTEC OBSERVED THAT THE VENTILATOR 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 17638473 ↗
• MalfunctionAug 4, 2023Output 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. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17467001 ↗

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