VOCSN V+O+C+S+N+Pro, EnglishRecalls & reported problems

Summary

The FDA's MAUDE database contains 366 adverse event reports that list this exact device (DI 00855573007792), received between Jun 22, 2019 and Sep 29, 2026 — classified as 21 injuries, 345 malfunctions.

The most frequently reported specific device problem is “Output Problem” (234 reports).

3 FDA recall records name this device's identifier, 3 still open.

2 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 8, 2026Class IIOpen, Classified

   Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of primary power and absence/depletion of backup power sources, which may result in delayed caregiver awareness of a hazardous condition.

   Z-2525-2026 · Root cause: Vendor change control · Recall details · FDA record ↗

2. Feb 3, 2025Class IOpen, Classified

   Multi-Function Ventilators were serviced using incorrect parts which have the potential to cause unexpected shutdown, or when using an active circuit could result in inaccurate tidal volume monitor, not triggering on patient efforts, less inspiratory volume, less inspiratory pressure, and less PEEP delivered.

   Z-1196-2025 · Root cause: Component change control · Recall details · FDA record ↗

3. 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 366 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Use of Device Problem

  Patient problems: Discomfort

  MAUDE report 50941194 ↗
• MalfunctionJun 30, 2026Display or Visual Feedback Problem

  IT WAS REPORTED TO VENTEC THAT THE LCD TOUCHSCREEN ON THE DEVICE WAS UNRESPONSIVE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673945 ↗
• MalfunctionJun 4, 2026Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE WAS "BARELY BLOWING ANY AIR" HOWEVER NO FURTHER DESCRIPTION WAS PROVIDED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25402338 ↗
• MalfunctionJun 1, 2026Output 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 25352339 ↗
• MalfunctionMay 27, 2026Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25311236 ↗
• MalfunctionMay 27, 2026Output 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 25311120 ↗
• MalfunctionMay 26, 2026Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. DURING THE DEVICE'S EVALUATION, VENTEC OBSERVED THAT IT 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 25285003 ↗
• MalfunctionMay 21, 2026Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT MEASURED LOWER PEEP (POSITIVE END EXPIRATORY PRESSURE) THAN SET AND WAS DISPLAYING A PATIENT CIRCUIT DISCONNECT ALARM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250797 ↗
• MalfunctionMay 13, 2026Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT 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 25163286 ↗
• MalfunctionMay 12, 2026Output 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 ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25156370 ↗
• MalfunctionMay 7, 2026Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. DURING THE DEVICE'S EVALUATION, VENTEC OBSERVED THAT IT WAS PROVIDING LOW FIO2 (FRACTION OF INSPIRED OXYGEN) READINGS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25119708 ↗
• MalfunctionMay 1, 2026Output 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 25059311 ↗
• MalfunctionApr 30, 2026Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. DURING THE DEVICE'S EVALUATION, VENTEC OBSERVED THAT IT 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 25053352 ↗
• MalfunctionApr 30, 2026Output 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 25038869 ↗
• MalfunctionApr 29, 2026Display or Visual Feedback Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE HAD A "PROBLEM WITH THE SCREEN". VENTEC FOLLOWED-UP WITH THE INITIAL REPORTER TO ASK IF THE DEVICE'S LCD TOUCHSCREEN WAS RESPONSIVE TO TOUCHES, AND THEY RESPONDED WITH "WE WERE UNABLE TO DETERMINE THAT, AS THE SCREEN WAS FLICKERING." THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25038447 ↗
• MalfunctionApr 27, 2026Output 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 WAS DISPLAYING A PATIENT CIRCUIT DISCONNECT ALARM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25009335 ↗
• MalfunctionApr 16, 2026Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE POWERED OFF UNEXPECTEDLY DURING USE, THEN BEGAN TO CONTINUOUSLY REBOOT BY ITSELF. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT; HOWEVER, THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. THE PATIENT WAS PLACED ON THEIR BACKUP VENTILATOR FOR SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24906140 ↗
• MalfunctionApr 15, 2026Unexpected Shutdown

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT 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 24891848 ↗
• MalfunctionApr 9, 2026Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT HAD NO VENTILATION OUTPUT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24837880 ↗
• MalfunctionApr 3, 2026Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE POWERED OFF UNEXPECTEDLY DURING USE, THEN REBOOTED BY ITSELF. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT; HOWEVER, THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24781992 ↗
• MalfunctionMar 23, 2026Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT WAS DISPLAYING THE PATIENT CIRCUIT DISCONNECT ALARM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24671474 ↗
• MalfunctionMar 23, 2026Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT 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 24671203 ↗
• MalfunctionMar 20, 2026Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT WAS DISPLAYING THE PATIENT CIRCUIT DISCONNECT ALARM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24655159 ↗
• MalfunctionMar 19, 2026Device Alarm System

  IT WAS REPORTED TO VENTEC THAT THE DEVICE DID NOT PROVIDE A PATIENT CIRCUIT DISCONNECT ALARM WHEN THE PATIENT WAS REMOVED FROM THE VENTILATOR. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. THE PATIENT HAD GONE INTO CARDIAC ARREST AND PERSONNEL HAD REMOVED THE VENTILATOR IN ORDER TO CARE FOR THE PATIENT. THERE WAS NO ALLEGATION THAT THE DEVICE USE HAD CONTRIBUTED TO THE PATIENT'S CARDIAC ARREST, ONLY THAT PERSONNEL HAD EXPECTED TO HEAR THE ALARM WHEN THE PATIENT WAS DISCONNECTED FROM THE VENTILATOR. THE PATIENT SURVIVED THE REPORTED EVENT. VENTEC MADE MULTIPLE ATTEMPTS TO CONTACT THE INITIAL REPORTER IN ORDER TO OBTAIN PATIENT INFORMATION, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24645977 ↗
• MalfunctionMar 18, 2026Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT HAD NO VENTILATION OUTPUT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24635616 ↗

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-1942-2026 · Mar 25, 2026 · Open, Classified
  VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000
• 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