VOCSN V+C, EnglishRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00855573007730), received between Aug 26, 2019 and May 18, 2026 — classified as 3 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Unexpected Shutdown” (12 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026No Display/Image

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT HAD A BLACK LCD TOUCHSCREEN WHEN POWERED ON. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25211414 ↗
• MalfunctionMay 15, 2026Output Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25193179 ↗
• InjuryApr 29, 2026Device Alarm System; Output Problem

  THE FDA PROVIDED VENTEC WITH A COPY OF MEDWATCH REPORT MW5186083 WHICH STATED THE FOLLOWING: "MY HUSBAND HAS BEEN ON A VENTILATOR 24/7 FOR APPROXIMATELY 8 YEARS. LAST WEEK HIS DME (DURABLE MEDICAL EQUIPMENT) SWITCHED HIM FROM HIS OLD VENT TO A VOCSN (VENTILATION, OXYGEN CONCENTRATOR, COUGH ASSISTANCE, SUCTION, AND NEBULIZER). MY "TRAINING" LASTED APPROXIMATELY 15 MINUTES. I HAVE SINCE LEARNED THAT YOU SHOULD NEVER SWITCH A VENTILATOR AT HOME. IT SHOULD BE DONE IN THE HOSPITAL UNDER THE SUPERVISION OF A PHYSICIAN. THE VERY NEXT DAY, IT WAS BY SHEER CHANCE THAT I CHECKED ON HIM WHEN I DID. I FOUND HIM BLUE, UNRESPONSIVE, IN A-FIB WITH O2 OF 35%. THE ALARM ON THE VENT NEVER SOUNDED. WHILST CALLING 911, I SWITCHED HIM BACK TO HIS OLD VENT AND IT IMMEDIATELY BEGAN ALARMING. HE NEARLY LOST HIS LIFE DUE TO THIS MALFUNCTION. HE REMAINS IN THE ICU, RETURNING HOME TOMORROW UNDER THE CARE OF A DIFFERENT DME COMPANY. I HAVE ALSO LEARNED THAT THE CIRCUITS VIEMED HAS BEEN PROVIDING ARE NOT MEANT FOR INVASIVE VENTILATION. THEY ARE, IN FACT, BIPAP/CPAP HOSES WHICH DO NOT PROVIDE THE CORRECT PRESSURES. I AM VERY CONCERNED THIS WILL HAPPEN TO SOMEONE ELSE WHO MAY NOT BE AS "LUCKY" AS MY HUSBAND. THE

  Patient problems: Arrhythmia; Cyanosis; Loss of consciousness; Low Oxygen Saturation

  MAUDE report 25038380 ↗
• MalfunctionApr 13, 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 24853470 ↗
• MalfunctionMar 18, 2026Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE POWERED OFF UNEXPECTEDLY 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. THE PATIENT WAS PLACED ON THEIR BACK-UP VENTILATOR FOR SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24635598 ↗
• MalfunctionFeb 25, 2026Device Alarm System

  IT WAS REPORTED TO VENTEC THAT THE DEVICE DID NOT PROVIDE A PATIENT CIRCUIT DISCONNECT ALARM AS EXPECTED, WHEN THE PATIENT HAD BECOME DISCONNECTED FROM THE DEVICE. 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 24449975 ↗
• InjuryFeb 19, 2026Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE ALARMED AND THEN POWERED OFF UNEXPECTEDLY DURING USE. THE INITIAL REPORTER ADVISED THAT THE PATIENT WAS THEN PROVIDED WITH MANUAL VENTILATED UNTIL THEY WERE ABLE TO BE PLACED ON THEIR BACKUP VENTILATOR. THE PATIENT SURVIVED THE REPORTED EVENT; 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 24397060 ↗
• MalfunctionJan 9, 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 24024710 ↗
• MalfunctionJan 9, 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 24024275 ↗
• MalfunctionOct 30, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THE DEVICE NEEDED SERVICE. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT IT WAS DELIVERING 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 23432532 ↗
• MalfunctionSep 12, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE UNEXPECTEDLY POWERED OFF 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 23042518 ↗
• MalfunctionJul 30, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE UNEXPECTEDLY POWERED OFF BY ITSELF DURING USE. THERE WAS PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE, 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 22671529 ↗
• MalfunctionJul 28, 2025Output Problem; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE WAS DELIVERING HIGHER THAN SET PEEP (POSITIVE END EXPIRATORY PRESSURE). 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 22638287 ↗
• MalfunctionJul 25, 2025Output Problem; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE NEEDED SERVICE AS IT WAS "NOT READING VT AS IT SHOULD." NO FURTHER DETAILS OR CLARIFICATION WAS PROVIDED. 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. UPON EVALUATION OF THE DEVICE, VENTEC OBSERVED THAT ITS EXHALED TIDAL VOLUME (VTE) LEVELS WERE LOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22620479 ↗
• MalfunctionJul 7, 2025Device Alarm System; Device Alarm System

  IT WAS REPORTED TO VENTEC THAT THE DEVICE'S ALARMS WERE NOT WORKING AS EXPECTED DURING USE. THE INITIAL REPORTER ADVISED THAT THE PATIENT CIRCUIT HAD BECOME DISCONNECTED FOR AN EXTENDED PERIOD AND THERE WERE NO ALARMS. THERE WAS PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE. HOWEVER, THERE WAS NO PATIENT HARM, AS THE VENT WAS PROMPTLY SWAPPED OUT. NO FURTHER DETAILS ABOUT THE PATIENT WERE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22428315 ↗
• InjuryMay 30, 2025Output Problem; Output Problem

  A DISTRIBUTOR CONTACTED VENTEC VIA EMAIL TO REPORT THE FOLLOWING PATIENT RELATED EVENT: "RECEIVED A PHONE CALL (B)(6) 2025 @ 1935) FROM SPOUSE/CAREGIVER THAT VENTILATOR IS NOT WORKING RIGHT. DAUGHTER TOOK OVER THE PHONE AND SAID THERE IS BLOOD WHILE SUCTIONING. DAUGHTER SAID THEY WERE DOING A DUONEB TREATMENT AND THE VENTILATOR STARTED ALARMING, AND THE TIDAL VOLUME WAS FLASHING 2000 ML. TOLD DAUGHTER TO DISCONNECT PATIENT FROM VENTILATOR AND MANUALLY BAG THE PATIENT. SHE SAID PATIENT SPO2 100% AND NEVER DESATURATED. INFORMED DAUGHTER I WILL BE THERE AS SOON AS I CAN TO TROUBLESHOOT VENTILATOR AND ASSESS PATIENT. UPON ARRIVAL TO PATIENT¿S HOME, PATIENT PRESENTS IN HOME HOSPITAL BED WITH TRACHEOSTOMY (#8 SHILEY CUFFED) IN PLACE CONNECTED TO BAG-VALVE MASK @ 3 L/M RECEIVING MANUAL BREATHS BY DAUGHTER. PATIENTS HEART RATE 110 WITH SPO2 OF 100%. PINK/ BLOOD-TINGED SECRETIONS NOTED, NO BLOOD CLOTS OR BRIGHT RED BLOOD SEEN IN SUCTION CANISTER. BREATH SOUNDS NOTED IN ALL LOBES. CUFF HAD AIR AND PATIENT WAS SUCTIONED TO MAKE SURE AIRWAY WAS PATENT. AND PATIENT WAS EASY TO BAG WITHOUT RESISTANCE. VENTILATOR WAS CHECKED TO MAKE SURE EVERYTHING WAS WORKING AND CONNECTED PROPERLY. DAUGHTER WAS

  Patient problems: Discomfort

  MAUDE report 22120015 ↗
• MalfunctionMay 16, 2025Output Problem; Output Problem

  IT WAS REPORTED TO VENTEC THAT THE DEVICE WAS DELIVERING LOW VTE (EXHALED TIDAL VOLUME). THE DEVICE ALSO DISPLAYED THE LOW INSPIRATORY PRESSURE ALARM. THERE WAS NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039018 ↗
• MalfunctionFeb 3, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE VOCSN DEVICE WOULD CONTINUOUSLY REBOOT BY ITSELF AFTER INITIATING COUGH THERAPY. THERE WAS PATIENT USE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTER ADVISED THAT THERE WAS NO HARM TO THE PATIENT AS A RESULT OF THE REPORTED ISSUE. THE EVENT WAS INITIALLY REPORTED TO A REACT HEALTH VENTILATION PRODUCT SPECIALIST BY THE PATIENT¿S FATHER. FOR PRIVACY REASONS, VENTEC HAS ENTERED THE REACT HEALTH EMPLOYEE¿S CONTACT INFORMATION IN SECTION E1, INITIAL REPORTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21289405 ↗
• MalfunctionDec 11, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED TO VENTEC THAT THE DEVICE'S ALARM WAS NOT WORKING AS EXPECTED, STATING THAT THE "ALARM/ NURSE CALL JACK NOT WORKING". VENTEC REACHED OUT TO THE REPORTER FOR ADDITIONAL INFORMATION/CLARIFICATION OF THE REPORTED ISSUE AND WAS ADVISED THAT NO FURTHER INFORMATION WAS AVAILABLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20906709 ↗
• MalfunctionNov 26, 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) AND WAS DELIVERING HIGHER THAN SET PEEP (POSITIVE END EXPIRATORY PRESSURE). HIGH PEEP DELIVERY WOULD CAUSE THE DEVICE TO DISPLAY THE HIGH PEEP ALARM. THERE WERE NO REPORTS OF PATIENT USE ASSOCIATED WITH THE REPORTED ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20789838 ↗
• MalfunctionOct 30, 2024Output Problem; Output 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 20571350 ↗
• MalfunctionSep 13, 2024Display or Visual Feedback Problem; Unexpected Shutdown; Display or Visual Feedback Problem; Unexpected Shutdown

  IT WAS REPORTED TO VENTEC THAT THE DEVICE WAS REBOOTING CONTINUOUSLY. WHEN THIS OCCURRED, THE LCD TOUCHSCREEN ON THE DEVICE WAS ALSO LOCKED-UP AND UNRESPONSIVE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20213872 ↗
• MalfunctionAug 14, 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 19987312 ↗
• MalfunctionMay 3, 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. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19244292 ↗
• MalfunctionMar 22, 2023Unexpected Shutdown; Unexpected Shutdown

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16592064 ↗

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