Pneupac 100/905/300-CHRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019517159127), received between Jul 6, 2021 and Apr 5, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (4 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 5, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUSTOMER NOTICED THE CORRUGATED TUBE WAS UNABLE TO BE CONNECTED TO THE PATIENT-SIDE VALVE. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16686718 ↗
• MalfunctionMar 22, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, THE AIRWAY ADAPTER WAS UNABLE TO BE CONNECTED OR RETAINED TO THE DISPOSABLE BREATHING CIRCUIT. NO REPORT OF PATIENT INJURY. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16591329 ↗
• MalfunctionOct 13, 2022Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE CUSTOMER ATTEMPTED TO CONNECT THE PRODUCT WITH A DEVICE AT A PRE-USE CHECK, BUT COULD NOT DO IT SUCCESSFULLY BECAUSE OF A LOOSE CONNECTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15595594 ↗
• MalfunctionJul 6, 2021Connection Problem; Connection Problem

  INFORMATION RECEIVED A SMITHS MEDICAL VENTILATORS/PNEUPAC DISPOSABLE CIRCUITS MALFUNCTIONED. REPORTED DURING THE USE OF THE PRODUCT, THE CUSTOMER NOTICED THE CONNECTION BETWEEN THE PRODUCT AND THE TUBE WAS DISCONNECTED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125713 ↗