Ventlab HS4011Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10889483110850), received between Jun 1, 2022 and Jun 18, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2025Break; Break

  IT WAS REPORTED, THE ENDOTRACHEAL TUBE WAS ATTACHED TO A BAGGED PATIENT WHEN THEY NOTICED PART OF THE CLEAR PLASTIC PART OF THE MANOMETER PIECE WAS BROKEN. IT WAS REPLACED WITH ANOTHER DEVICE; THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286410 ↗
• MalfunctionNov 17, 2023Leak/Splash; Leak/Splash

  THE BAG WAS LEAKING AIR. THE PATIENT IN THE PACU REQUIRED SUPPORT WITH BREATHING. THE CRNA REQUESTED A BAG VALVE MASK AND RECEIVED A 1L HYPERINFLATION SYSTEM + MANOMETER FROM VENTLAB (SUNMED). AFTER HOOKING UP THE OXYGEN THE CRNA ATTEMPTED VENTILATION AND NOTICED THE BAG LEAKING. ON INSPECTION, THE INFLATION BAG HAD SEVERAL SMALL CUTS THAT PREVENTED GOOD VENTILATION. A REPLACEMENT (SAME PRODUCT) WAS QUICKLY OBTAINED AND THE PATIENT WAS TREATED WITHOUT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18165397 ↗
• MalfunctionOct 20, 2023

  THE PATIENT IN THE PACU REQUIRED SUPPORT WITH BREATHING. THE CRNA REQUESTED A BAG VALVE MASK AND RECEIVED A 1L HYPERINFLATION SYSTEM + MANOMETER FROM VENTLAB (SUNMED). AFTER HOOKING UP THE OXYGEN THE CRNA ATTEMPTED VENTILATION AND NOTICED THE BAG LEAKING. ON INSPECTION, THE INFLATION BAG HAD SEVERAL SMALL CUTS THAT PREVENTED GOOD VENTILATION. A REPLACEMENT (SAME PRODUCT) WAS QUICKLY OBTAINED AND THE PATIENT WAS TREATED WITHOUT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17975566 ↗
• MalfunctionJun 1, 2022Decrease in Pressure

  THE COMMITTEE ON TECHNOLOGY FOR THE ANESTHESIA PATIENT SAFETY FOUNDATION RECEIVED A REPORT REGARDING OUR HYPERINFLATION SYSTEM. DESCRIBING THE DESIGN AS COUNTER-INTUITIVE AND THAT IT DOES NOT CONFORM WITH ISO STANDARD RECOMMENDATIONS. A NEAR MISS OCCURRED WHERE POSITIVE PRESSURE WAS DESIRED AND THE VALVE WAS TURNED CLOCKWISE WITH THE EXPECTATION OF INCREASING PRESSURE. HOWEVER; THIS LED TO DECREASING PRESSURE IN THE HYPERINFLATION SYSTEM. THE PROBLEM WAS REMEDIED BY QUICK OBSERVATION THAT TO CLOSE THE VALVE, THE VALVE MUST BE TURNED ANTI-CLOCKWISE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14570258 ↗
• MalfunctionJun 1, 2022Manufacturing, Packaging or Shipping Problem

  THE COMMITTEE ON TECHNOLOGY FOR THE ANESTHESIA PATIENT SAFETY FOUNDATION RECEIVED A REPORT REGARDING OUR HYPERINFLATION SYSTEM DESCRIBING THE DESIGN AS COUNTER-INTUITIVE AND THAT IT DOES NOT CONFORM WITH ISO STANDARD RECOMMENDATIONS. A NEAR MISS OCCURRED WHERE POSITIVE PRESSURE WAS DESIRED AND THE VALVE WAS TURNED CLOCKWISE WITH THE EXPECTATION OF INCREASING PRESSURE, HOWEVER THIS LED TO DECREASING PRESSURE IN THE HYPERINFLATION SYSTEM. THE PROBLEM WAS REMEDIED BY QUICK OBSERVATION THAT TO CLOSE THE VALVE, THE VALVE MUST BE TURNED ANTI-CLOCKWISE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14569757 ↗