VOCSN V+O+C+S+N+Pro, Japanese (REF PRT-00490-1XX)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00855573007204), received between Jan 10, 2020 and Mar 24, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Output Problem” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2025Output Problem; Output Problem

  AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT AFTER APPROXIMATELY 3 HOURS OF TESTING THE DEVICE, IT STOPPED VENTILATING AND ALARMED DUE TO LOW INSPIRATORY PRESSURE. THERE WAS NO PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21680665 ↗
• MalfunctionMar 13, 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 18895972 ↗
• MalfunctionApr 3, 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 WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16670933 ↗
• MalfunctionMar 4, 2020Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE FAILED TO VENTILATE WHILE A PATIENT WAS UNDER TREATMENT. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9789413 ↗
• MalfunctionJan 10, 2020Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE FAILED TO VENTILATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9578718 ↗

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