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

Summary

The FDA's MAUDE database contains 286 adverse event reports that list this exact device (DI 00855573007747), received between Oct 4, 2019 and Sep 29, 2026 — classified as 15 injuries, 271 malfunctions.

The most frequently reported specific device problem is “Output Problem” (128 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 286 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Use of Device Problem

  Patient problems: Discomfort

  MAUDE report 50941181 ↗
• MalfunctionMay 29, 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 25340875 ↗
• MalfunctionMay 15, 2026Device Alarm System

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT ITS ALARM WAS NOT WORKING AS EXPECTED. THE DEVICE WAS INTERMITTENTLY SILENCING THE AUDIBLE ALARMS AT START UP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25194270 ↗
• MalfunctionApr 24, 2026Unexpected Shutdown

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC DOWNLOADED ITS ELECTRONIC RECORDS (SYSTEM LOGS) FOR REVIEW WHERE IT WAS OBSERVED THAT THE DEVICE HAD LOGGED PREVIOUS INSTANCES OF THE DEVICE REBOOTING UNEXPECTEDLY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE OBSERVED REBOOT EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24990951 ↗
• MalfunctionApr 23, 2026Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT THE DEVICE WAS DELIVERING AN UNEXPECTED (LOW) BREATH RATE AND LOW INSPIRATORY PRESSURE. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24974638 ↗
• MalfunctionApr 22, 2026Device Alarm System; Output Problem

  IT WAS REPORTED TO VENTEC THAT A DEVICE HAD NO VENTILATION OUTPUT, AND THAT IT DID NOT PROVIDE A PATIENT CIRCUIT DISCONNECT ALARM WHEN THE PATIENT CIRCUIT 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. VENTEC HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION ABOUT THE PATIENT, BUT NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958565 ↗
• MalfunctionApr 20, 2026Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE WAS POWERING ON AND OFF BY ITSELF. THE PATIENT'S CAREGIVER (MOTHER) WHO INITIALLY OBSERVED THE REPORTED ISSUE, ADVISED THAT SHE AND HER DAUGHTER HAD JUST RETURNED HOME FROM AN APPOINTMENT. DURING THE APPOINTMENT, THE PATIENT WAS UTILIZING HER PORTABLE VENTILATOR FOR SUPPORT. UPON RETURNING HOME, THE MOTHER POWERED ON HER DAUGHTERS BEDSIDE VENTILATOR WHEN SHE OBSERVED IT REBOOTING BY ITSELF. THE DAUGHTER REMAINED ON HER PORTABLE VENTILATOR UNTIL A NEW BEDSIDE VENTILATOR COULD BE OBTAINED. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT AS THE PATIENT WAS NOT ON THE VOCSN WHEN THE REPORTED REBOOT WAS OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24933343 ↗
• MalfunctionApr 11, 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 24849209 ↗
• MalfunctionApr 9, 2026Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. DURING THE DEVICE EVALUATION, VENTEC OBSERVED THAT IT WAS UNABLE TO MAINTAIN PEEP (POSITIVE END EXPIRATORY PRESSURE) 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 24837777 ↗
• MalfunctionApr 3, 2026Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24775647 ↗
• MalfunctionApr 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 (0). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24760665 ↗
• 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 24634526 ↗
• MalfunctionMar 15, 2026Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT HAD NO VENTILATION OUTPUT. ADDITIONALLY, THE DEVICE 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 24602079 ↗
• MalfunctionMar 15, 2026Unexpected Shutdown

  THE FOLLOWING EVENT WAS REPORTED TO VENTEC VIA EMAIL: "IN THE MIDDLE OF A ROUTINE COUGH ASSIST, THE STOPPED BOTH THE COUGH ASSIST AND THE VENTILATION. NEEDLESS TO SAY, MY CAREGIVER HAD TO AMBU BAG ME WHILE TRYING TO FIGURE OUT WHAT HAPPENED AND GET ME ON MY 2ND VENT.". VENTEC REACHED OUT TO THE PATIENT WHO HAD SENT THE EMAIL AND WAS PROVIDED WITH THEIR RESPIRATORY THERAPIST'S (RT) INFORMATION. VENTEC CONTACTED THE RT AND WAS ADVISED THAT THE DEVICE HAD PROVIDED A "SYSTEM FAULT" ALARM ON ITS SCREEN, BEEPED, THEN SHUT OFF BEFORE BEGINNING TO CONTINUOUSLY REBOOT ON ITS OWN. THERE WAS NO PATIENT HARM AS A RESULT OF THE REPORTED ISSUE, HOWEVER, MEDICAL INTERVENTION (MANUAL VENTILATION) WAS REQUIRED TO PREVENT PERMANENT IMPAIRMENT/DAMAGE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24601884 ↗
• MalfunctionMar 15, 2026Use of Incorrect Control/Treatment Settings

  IT WAS REPORTED TO VENTEC THAT THE DEVICE WAS NOT PROVIDING A PATIENT CIRCUIT DISCONNECT ALARM WHEN THE CIRCUIT WAS 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 WERE PROVIDED. VENTEC MADE MULTIPLE ATTEMPTS TO CONTACT THE INITIAL REPORTER IN ORDER TO OBTAIN PATIENT INFORMATION, HOWEVER, NO RESPONSE HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24601684 ↗
• MalfunctionMar 13, 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 ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594601 ↗
• MalfunctionMar 12, 2026Unexpected Shutdown

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT POWERED OFF UNEXPECTEDLY. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586028 ↗
• MalfunctionMar 12, 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 ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24585597 ↗
• MalfunctionMar 9, 2026Unexpected Shutdown

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24553828 ↗
• MalfunctionFeb 13, 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 24337864 ↗
• MalfunctionFeb 2, 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 ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24229245 ↗
• MalfunctionJan 20, 2026Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE UNEXPECTEDLY POWERED OFF DURING USE. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. THE PATIENT WAS PLACED ON THEIR BACKUP VENTILATOR FOR SUPPORT. THE REPORTER ADVISED THAT THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24126597 ↗
• MalfunctionJan 14, 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 ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24065073 ↗
• MalfunctionJan 5, 2026Output Problem

  AN AUTHORIZED SERVICE PROVIDER (ASP) CONTACTED VENTEC TO REPORT THAT THE DEVICE WAS DELIVERING AN UNEXPECTED BREATH RATE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23969998 ↗
• MalfunctionDec 1, 2025Output Problem; Output 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 23687102 ↗

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