VOCSN VOCSN, EnglishRecalls & reported problems

Summary

The FDA's MAUDE database contains 96 adverse event reports that list this exact device (DI 00855573007006), received between Apr 16, 2018 and Jun 5, 2026 — classified as 1 death, 4 injuries, 91 malfunctions.

The most frequently reported specific device problem is “Output Problem” (47 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 25 most recent of 96 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 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 USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25418208 ↗
• MalfunctionJun 5, 2026Output Problem

  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 EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25417852 ↗
• MalfunctionMay 19, 2026Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25224873 ↗
• MalfunctionMar 18, 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 USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634594 ↗
• MalfunctionFeb 16, 2026Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THE DEVICE 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 24357310 ↗
• MalfunctionJan 12, 2026Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE HAD POWERED OFF UNEXPECTEDLY DURING USE. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE; HOWEVER, THE REPORTER CONFIRMED THAT THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24049115 ↗
• MalfunctionSep 3, 2025Output Problem; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE WAS PROVIDING INACCURATE FIO2 (FRACTION OF INSPIRED OXYGEN) READINGS, ADVISING THAT THE "FIO2 OXYGEN SENSOR BAD". THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22957676 ↗
• MalfunctionAug 21, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED TO VENTEC THAT THE DEVICE'S ALARM WAS NOT WORKING AS EXPECTED. THE REPORTER ADVISED THAT THE DEVICE DID NOT PROVIDE A PATIENT CIRCUIT DISCONNECT ALARM WHEN THE PATIENT HAD BEEN DISCONNECTED. 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 HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE REPORTER IN ORDER TO OBTAIN ADDITIONAL INFORMATION, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22868741 ↗
• MalfunctionMay 30, 2025Output Problem; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE WAS DELIVERING AN ERRATIC BREATH RATE, ERRATIC (LOW) VTE (EXHALED TIDAL VOLUME) AND WAS UNABLE TO MAINTAIN SET PEEP (POSITIVE END EXPIRATORY PRESSURE). THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22119735 ↗
• MalfunctionMay 27, 2025Output Problem; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE 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 22092104 ↗
• MalfunctionApr 28, 2025Output 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 21923380 ↗
• MalfunctionMar 28, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT WAS UNABLE TO MAINTAIN 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 21727228 ↗
• MalfunctionMar 6, 2025Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21543018 ↗
• MalfunctionJan 8, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE UNEXPECTEDLY SHUT DOWN BY ITSELF DURING USE. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. THE REPORTER ADVISED THAT THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. THE PATIENT WAS PLACED ON THEIR BACKUP VENTILATOR FOR SUPPORT. VENTEC HAS MADE MULTIPLE ATTEMPTS TO CONTACT THE REPORTER IN ORDER TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21108021 ↗
• MalfunctionDec 11, 2024Output Problem; Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20909622 ↗
• MalfunctionOct 28, 2024Output 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 20547194 ↗
• MalfunctionOct 14, 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 20447563 ↗
• MalfunctionOct 3, 2024Output Problem; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE HAD NO VENTILATION OUTPUT. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20360007 ↗
• MalfunctionSep 6, 2024Output Problem; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE'S EXHALED TIDAL VOLUME (VTE) LEVELS WERE LOW AND THAT IT APPEARED TO HAVE LOW FLOW. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20160303 ↗
• MalfunctionAug 13, 2024Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE VENTEC OBSERVED THAT IT WOULD REBOOT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977738 ↗
• MalfunctionJul 24, 2024Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. DURING THE DEVICE EVALUATION VENTEC OBSERVED THAT THE VENTILATOR MEASURED LOWER PEEP (POSITIVE END EXPIRATORY PRESSURE) THAN SET AND THAT ITS EXHALED TIDAL VOLUME (VTE) LEVELS WERE LOW. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19819199 ↗
• MalfunctionJul 15, 2024Unexpected Shutdown; Unexpected Shutdown

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19747186 ↗
• MalfunctionJul 15, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED TO VENTEC THAT THE DEVICE HAD AN ISSUE WITH ITS ALARM SYSTEM. VENTEC REACHED OUT TO THE REPORTER ASKING IF THEY COULD CLARIFY THE REPORTED ISSUE, BUT THEY RESPONDED WITH "I HAVE NO IDEA JUST SAID ALARMS UNABLE TO USE ON TAG". THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19744420 ↗
• MalfunctionJul 9, 2024Output Problem; Unexpected Shutdown; Output Problem; Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE WAS CONTINUOUSLY REBOOTING BY ITSELF DURING USE. THE REPORTER ALSO STATED THAT THE DEVICE WAS NOT PROVIDING ANY VENTILATION OUTPUT AS WELL. 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 19705204 ↗
• MalfunctionJun 26, 2024Output Problem; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE HAD NO VENTILATION OUTPUT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19618159 ↗

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