VOCSN V+C+Pro, EnglishRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00855573007778), received between Jun 20, 2023 and Jun 29, 2026 — classified as 3 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Output Problem” (14 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2026Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE 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 25661743 ↗
• MalfunctionMay 21, 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 25250555 ↗
• MalfunctionMay 21, 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 25250550 ↗
• MalfunctionMay 19, 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 25219422 ↗
• MalfunctionApr 29, 2026Display or Visual Feedback Problem

  IT WAS REPORTED TO VENTEC THAT THE LCD TOUCHSCREEN ON THE DEVICE WAS UNRESPONSIVE. 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 WAS PROVIDED. VENTEC CONTACTED THE INITIAL REPORTER FOR ADDITIONAL INFORMATION ABOUT THE PATIENT, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25038464 ↗
• MalfunctionApr 15, 2026Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE WAS UNABLE TO MAINTAIN FIO2 (FRACTION OF INSPIRED OXYGEN) LEVELS DURING USE, FURTHER STATING THAT THE DEVICE PROVIDED AN ALARM INDICATING LOW FIO2 READINGS. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. THE PATIENT'S RESPIRATORY THERAPIST (RT) ADVISED THAT THIS EVENT DID NOT AFFECT THE PATIENT IN ANY WAY, AND THAT THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. THE PATIENT WAS PLACED ON A DIFFERENT VENTILATOR FOR SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24891769 ↗
• MalfunctionApr 11, 2026Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE CONTINUOUSLY REBOOTS BY ITSELF. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24852743 ↗
• MalfunctionMar 5, 2026Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE "WAS NOT BLOWING LIKE NORMAL" (I.E. LOW TO NO VENTILATION OUTPUT). THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT; HOWEVER, THERE WAS NO PATIENT HARM AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24515335 ↗
• MalfunctionFeb 2, 2026Output 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 INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24229242 ↗
• MalfunctionFeb 2, 2026Display or Visual Feedback Problem

  IT WAS REPORTED TO VENTEC THAT THE LCD TOUCHSCREEN ON THE DEVICE BECAME UNRESPONSIVE DURING USE. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. THE REPORTER ADVISED THAT THERE WAS NO PATIENT HARM AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24229231 ↗
• MalfunctionNov 19, 2025Device Alarm System; Unexpected Shutdown; Device Alarm System; Unexpected Shutdown

  IT WAS REPORTED THAT THE DEVICE UNEXPECTEDLY POWERED OFF DURING USE, WHILE IT WAS PROVIDING VENTILATION, AND THAT IT DID NOT ALARM AS EXPECTED. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT; HOWEVER, THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. VENTEC HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT AND THE EVENT, BUT NO RESPONSE WAS RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597654 ↗
• InjuryNov 7, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO VENTEC THAT THE LCD TOUCHSCREEN ON THE DEVICE HAD LOCKED UP AND BECOME UNRESPONSIVE DURING USE. THE PATIENT WAS REMOVED FROM THE DEVICE AND PROVIDED WITH MANUAL VENTILATION WHILE OTHER PERSONNEL TROUBLESHOT THE DEVICE. PERSONNEL RESTARTED THE DEVICE AND RECALIBRATED ITS TOUCHSCREEN. AFTER WHICH, NORMAL OPERATION WAS OBSERVED AND THE PATIENT WAS PLACED BACK ON THE DEVICE FOR SUPPORT. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE; HOWEVER, MEDICAL INTERVENTION WAS REQUIRED TO PREVENT PERMANENT IMPAIRMENT/DAMAGE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501608 ↗
• MalfunctionNov 7, 2025Output Problem; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT THE 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 23500776 ↗
• MalfunctionAug 6, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE CONTINUOUSLY REBOOTS BY ITSELF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730698 ↗
• MalfunctionJul 9, 2025Output Problem; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE WAS DISPLAYING AN ALARM THAT THE DEVICE WAS DELIVERING 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 22462774 ↗
• MalfunctionJun 11, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE NEEDED SERVICE. DURING EVALUATION VENTEC OBSERVED 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 22187080 ↗
• MalfunctionJun 9, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE NEEDED SERVICE. DURING EVALUATION VENTEC OBSERVED 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 22172699 ↗
• MalfunctionMay 8, 2025Output Problem; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE'S FIO2 (FRACTION OF INSPIRED OXYGEN) MONITOR WAS NOT PROVIDING ACCURATE INFORMATION WHEN CONNECTED TO EXTERNAL O2. THE REPORTER ADVISED VENTEC THAT THE FIO2 MONITOR WAS ENABLED, BUT THE DEVICE KEPT SHOWING THAT IT WAS DISABLED. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986662 ↗
• MalfunctionMar 17, 2025Output Problem; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE WAS PROVIDING "INCONSISTENT" FIO2 (FRACTION OF INSPIRED OXYGEN) READINGS AND LOW TIDAL VOLUME LEVELS. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21626080 ↗
• InjuryJan 14, 2025Device Alarm System; Output Problem; Device Alarm System; Output Problem

  THE FOLLOWING EVENT WAS REPORTED TO VENTEC VIA EMAIL BY A FACILITY BIOMEDICAL TECHNICIAN: "RESPIRATORY THERAPY SENT ME A V+ PRO THAT IS REPORTING TOO HIGH OF PRESSURES. FROM THE LITTLE VERIFICATIONS I CAN DO IT APPEARS TO BE WORKING FINE ON THE BIOMET SIDE OF THINGS. BUT THERE IS CLEARLY A PROBLEM. WE HAVE HAD THE VENT FOR ABOUT 5 MONTHS NOW." THE BIOMEDICAL TECHNICIAN RESPONDED TO VENTEC¿S REQUEST FOR ADDITIONAL DETAILS BY PROVIDING THE FOLLOWING: "HIGH PEAK PRESSURES. THIS VENT HAS GREATER THAN 50 PRESSURES. SET UP ANOTHER VENT WITH SAME SETTINGS, PEAK PRESSURE WAS SIGNIFICANTLY LOWER." VENTEC THEN RECEIVED ADDITIONAL INFORMATION ABOUT THE PATIENT AND THE EVENT FROM THE FACILITY RESPIRATORY THERAPY (RT) CLINICAL COORDINATOR: "NO ALARMS, VISUAL SIGNS OF DISTRESS (VENT DESYNCHRONY, SPIKE IN VITALS) WE TRIED TWO DIFFERENT VOCSNS ON A TEST LUNG WITH THE SAME SETTINGS. THIS ONE HAD SIGNIFICANTLY HIGHER PEAK PRESSURES THAN THE OTHER ONE." VENTEC THEN ASKED WHAT PEEP WAS SET TO VS WHAT READING WAS OBSERVED DURING THE PATIENT EVENT. THE RT CLINICAL COORDINATOR ADVISED, "IT WAS SET AT 10 AND READING 10, ACCORDING TO THE CHARTING." THE RT CLINICAL COORDINATOR ADVISED VENTEC THAT THE PATIEN

  Patient problems: Distress

  MAUDE report 21154486 ↗
• MalfunctionNov 6, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT WAS CONTINUOUSLY REBOOTING BY ITSELF. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20616932 ↗
• MalfunctionAug 23, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT 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 20058045 ↗
• InjuryJan 18, 2024Connection Problem; Output Problem; Unexpected Shutdown; Connection Problem; Output Problem; Unexpected Shutdown

  THE FOLLOWING EVENT WAS REPORTED TO VENTEC: "VENT WAS PLACED ON A 24 HOUR VENT DEPENDENT PATIENT AROUND 1500CST. AROUND 2030CST THE DEVICE BEGAN TO ALARM ¿VENT SYSTEM FAILURE¿. THE STAFF GOT THINGS READY TO TRANSITION THE PATIENT TO ANOTHER VENT. AS THEY WERE PREPARING THE ALTERNATIVE VENT OPERATING DEVICE BEGAN TO ALARM ¿VENT INOP¿. THEY PROMPTLY REMOVED THE DEVICE FROM THE PATIENT AND BEGAN TO BAG THE PATIENT. DURING THAT TIME THE STAFF REPORTED THAT THE DEVICE JUST SHUT OFF. THEY WERE ABLE TO TRANSITION THE PATIENT TO THE ALTERNATIVE VENT." THE PATIENT SURVIVED THE REPORTED EVENT AND THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. HOWEVER, MEDICAL INTERVENTION WAS REQUIRED IN ORDER TO PREVENT PERMANENT IMPAIRMENT/DAMAGE TO THE PATIENT. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18539397 ↗
• MalfunctionJul 7, 2023Device Alarm System; Device Alarm System

  IT WAS REPORTED TO VENTEC THAT THE DEVICE'S ALARM WAS NOT WORKING AS EXPECTED. THE REPORTER ADVISED THAT IT WOULD NOT ALARM FOR LOW PRESSURE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17283173 ↗
• MalfunctionJun 20, 2023Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE CONTINUOUSLY REBOOTS BY ITSELF. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17164702 ↗

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