VOCSN-VC VOCSN-VC Pro, EnglishRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00855573007433), received between Feb 6, 2019 and Mar 10, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Output Problem” (15 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 10, 2026Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE'S EXHALED TIDAL VOLUME (VTE) LEVELS WERE LOW. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT; HOWEVER, THERE WAS NO PATIENT HARM AS A RESULT OF THE REPORTED ISSUE. THE PATIENT WAS PLACED ON THEIR BACKUP VENTILATOR FOR SUPPORT. NO FURTHER DETAILS ABOUT THE PATIENT WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24561055 ↗
• MalfunctionJan 6, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT UNEXPECTEDLY POWERED OFF BY ITSELF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21085113 ↗
• MalfunctionNov 18, 2024Power Problem; Power Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE FROZE IN THE MIDDLE OF A SOFTWARE UPDATE AND IS NOW INOPERABLE. VENTEC HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE REPORTER TO GET ADDITIONAL INFORMATION ABOUT THE REPORTED ISSUE, BUT NO RESPONSE HAS BEEN RECEIVED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20717576 ↗
• MalfunctionJul 18, 2024Output Problem; Output 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 19774021 ↗
• MalfunctionJun 21, 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 PROVIDED A LOWER THAN EXPECTED BREATH RATE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19582339 ↗
• MalfunctionJun 7, 2024Output Problem; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE'S "O2 SENSOR NOT WORKING." 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 19481545 ↗
• MalfunctionMay 17, 2024Output Problem; Output Problem

  IT WAS INITIALLY REPORTED TO VENTEC THAT THE DEVICE HAD PROVIDED A LOW FIO2 (FRACTION OF INSPIRED OXYGEN) ALERT DURING AN EVENT INVOLVING A PATIENT. VENTEC REACHED OUT TO THE REPORTER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT AND THE EVENT, AND WAS ADVISED THAT THEY WEREN'T SURE IF THEY COULD RELEASE THAT INFORMATION, AND THAT "I KNOW THE VENT WAS NOT ON THE PATIENT AND NO PATIENT HARM." VENTEC HAS REACHED OUT TO THE REPORTER MULTIPLE TIMES IN ORDER TO GET CLARIFICATION AS TO WHETHER OR NOT THERE WAS PATIENT USE. NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19347742 ↗
• MalfunctionFeb 20, 2024Output Problem; Output Problem

  IT WAS REPORTED TO VENTEC 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 18744596 ↗
• MalfunctionFeb 20, 2024Connection Problem; Output Problem; Connection Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. DURING THE DEVICE EVALUATION, VENTEC OBSERVED THAT THE VENTILATOR WAS UNABLE TO MAINTAIN PEEP (POSITIVE END EXPIRATORY PRESSURE), THAT ITS EXHALED TIDAL VOLUME (VTE) LEVELS WERE LOW AND THAT IT WAS DISPLAYING A PATIENT CIRCUIT DISCONNECT ALARM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18744562 ↗
• MalfunctionJul 18, 2023Output Problem; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE VENTILATOR PROVIDED 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 17344870 ↗
• MalfunctionMay 11, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED MAINTENANCE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT THE VENTILATOR PROVIDED AN ALARM INDICATING VERY LOW FIO2 (FRACTION OF INSPIRED OXYGEN) READINGS. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916756 ↗
• MalfunctionApr 28, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED MAINTENANCE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT THE VENTILATOR PROVIDED AN ALARM INDICATING VERY LOW FIO2 (FRACTION OF INSPIRED OXYGEN) READINGS. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16829730 ↗
• MalfunctionApr 27, 2023Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE NEEDED MAINTENANCE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THE DEVICE CONTINUOUSLY REBOOTED BY ITSELF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16827962 ↗
• MalfunctionMar 15, 2023Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED DATA IN THE DEVICE'S MEMORY WHICH INDICATED THAT IT HAD PREVIOUSLY REBOOTED MULTIPLE TIMES BY ITSELF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16550436 ↗
• MalfunctionMar 15, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. DURING THE DEVICE EVALUATION, VENTEC OBSERVED THAT ITS LCD TOUCHSCREEN WAS UNRESPONSIVE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16549969 ↗
• MalfunctionMar 7, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. DURING THE DEVICE EVALUATION, 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 16499225 ↗
• MalfunctionFeb 14, 2023Output Problem; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE WAS ALARMING DUE TO 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 16376413 ↗
• MalfunctionJan 31, 2023Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED MAINTENANCE. 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 16273141 ↗
• MalfunctionJan 16, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO VENTEC BY A THIRD PARTY SERVICE PROVIDER 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 16174906 ↗
• MalfunctionMay 11, 2020Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE FAILED THE PRE-USE TEST AND WOULD NOT VENTILATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10045045 ↗
• MalfunctionFeb 6, 2019Output Problem; Output Problem

  IT WAS REPORTED THAT A VENTILATOR WAS BEING SET UP AND DID NOT PASS THE PRE-USE TEST. IT WAS NOTED THAT THE UNIT WAS NOT VENTILATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8313041 ↗

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