VOCSN V*Home, EnglishRecalls & reported problems

Summary

The FDA's MAUDE database contains 318 adverse event reports that list this exact device (DI 00855573007822), received between Dec 1, 2023 and Sep 30, 2026 — classified as 4 deaths, 24 injuries, 290 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (130 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 318 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Output Problem

  Patient problems: Low Oxygen Saturation

  MAUDE report 50952873 ↗
• MalfunctionSep 24, 2026Unexpected Shutdown

  It was reported that the device needed service. Upon receipt of the device, Ventec downloaded its electronic records (System Logs) for analysis and observed that the device had previously powered off by itself.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 50885555 ↗
• MalfunctionSep 3, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50598680 ↗
• MalfunctionJun 30, 2026Display or Visual Feedback Problem

  AN AUTHORIZED THIRD PARTY SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE'S 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 25673924 ↗
• MalfunctionJun 30, 2026Use of Device Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE HAD DISPLAYED THE PATIENT CIRCUIT DISCONNECT ALARM. 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 25673879 ↗
• MalfunctionJun 25, 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 USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25631451 ↗
• MalfunctionJun 22, 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 EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25588408 ↗
• MalfunctionJun 22, 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 EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25581698 ↗
• MalfunctionJun 6, 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 EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25420685 ↗
• MalfunctionJun 6, 2026Device Alarm System

  IT WAS REPORTED TO VENTEC THAT THE DEVICE'S ALARM WAS NOT WORKING AS EXPECTED. THE DEVICE ALLEGEDLY DID NOT PROVIDE A PATIENT CIRCUIT DISCONNECT ALARM WHEN THE CIRCUIT HAD BEEN DISCONNECTED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25420664 ↗
• MalfunctionJun 6, 2026Device Alarm System

  IT WAS REPORTED TO VENTEC THAT THE DEVICE'S ALARM WAS NOT WORKING AS EXPECTED. THE DEVICE ALLEGEDLY DID NOT PROVIDE A PATIENT CIRCUIT DISCONNECT ALARM WHEN THE CIRCUIT HAD BEEN DISCONNECTED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25420658 ↗
• MalfunctionJun 5, 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 25417645 ↗
• MalfunctionJun 1, 2026Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT WAS PROVIDING INACCURATE 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 25356432 ↗
• InjuryMay 29, 2026Output Problem

  VENTEC RECEIVED A COPY OF A VOLUNTARY MEDWATCH REPORT WHICH STATED THE FOLLOWING: "PATIENT'S VENTILATOR INTERNAL FILTER DIRTY, CAUSING AIR TO BE BLOCKED. THE PATIENT HAD INCREASED WORK OF BREATHING, INCREASED RESPIRATORY RATE. THE VENTILATOR WAS SWITCHED OUT AND PATIENT'S SYMPTOMS RESOLVED." THE INITIAL REPORTER LATER CONFIRMED THAT THE PATIENT SURVIVED THE REPORTED EVENT. NO FURTHER DETAILS ABOUT THE PATIENT OR THE EVENT WERE PROVIDED. VENTEC REQUESTED ADDITIONAL INFORMATION REGARDING THE PATIENT, HOWEVER, THE INITIAL REPORTER DECLINED TO PROVIDE ANYTHING FURTHER.

  Patient problems: Increased Respiratory Rate

  MAUDE report 25340708 ↗
• MalfunctionMay 28, 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 USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25326219 ↗
• 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 25311494 ↗
• MalfunctionMay 21, 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 USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250792 ↗
• MalfunctionMay 21, 2026Device Alarm System; Output Problem

  VENTEC RECEIVED A COPY OF A VOLUNTARY MEDWATCH REPORT WHICH ADVISED OF THE FOLLOWING EVENT: "THE VENTILATOR CIRCUIT DISCONNECT ALARM DID NOT ALARM WHEN THE PATIENT BECAME DISCONNECTED FROM THE VENTILATOR. FAMILY ALSO REPORTED THE VENTILATOR SOUNDED DIFFERENT THAN IT NORMALLY DID AND STATED THE PRESSURE SOUNDED MORE 'MUFFLED' COMING FROM THE VENT (NOT AS LOUD)." VENTEC REACHED OUT TO THE INITIAL REPORTER FOR ADDITIONAL INFORMATION ABOUT THE PATIENT. VENTEC WAS ADVISED THAT THEY WERE UNABLE TO SHARE ANY ADDITIONAL INFORMATION ABOUT THE PATIENT, BUT DID CONFIRM THAT THERE WAS NO PATIENT HARM AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250679 ↗
• 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 USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25250635 ↗
• MalfunctionMay 19, 2026Display or Visual Feedback Problem

  IT WAS REPORTED TO VENTEC THAT THE LCD TOUCHSCREEN ON THE DEVICE HAD LOCKED-UP AND BECOME UNRESPONSIVE DURING USE. 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 25224796 ↗
• MalfunctionMay 12, 2026Display or Visual Feedback Problem; Use of Device 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 25156278 ↗
• MalfunctionMay 11, 2026Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT ITS BLOWER WAS NOT BLOWING CONSISTENTLY WHICH COULD LEAD TO INCONSISTENT/REDUCED VENTILATION OUTPUT. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143807 ↗
• MalfunctionMay 7, 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 USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25119755 ↗
• MalfunctionMay 1, 2026Display or Visual Feedback Problem

  IT WAS REPORTED TO VENTEC THAT A DEVICE, "HAS A CRACK INSIDE THE SCREEN THAT IS AFFECTING ON/OFF/STANDBY". VENTEC REACHED OUT TO THE INITIAL REPORTER ATTEMPTING TO GET ADDITIONAL INFORMATION ABOUT THE EVENT, BUT NO RESPONSE HAS BEEN RECEIVED. BASED ON WHAT HAD BEEN PROVIDED, IT IS LIKELY THAT THE 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 25061205 ↗
• MalfunctionApr 24, 2026Unexpected Shutdown

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24989784 ↗

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