Portex 100/905/300Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019315061066), received between Apr 22, 2020 and Apr 22, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Disconnection” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2020Disconnection; Loose or Intermittent Connection; Disconnection; Loose or Intermittent Connection

  INFORMATION WAS RECEIVED INDICATING THAT THE ONE-WAY VALVE TO A SMITHS MEDICAL PNEUPAC DISPOSABLE CIRCUIT BECAME DISCONNECTED. IT WAS REPORTED THAT THE CONNECTOR WAS EASILY DETACHED FROM THE PRODUCT FOLLOWING ATTACHING AN HME FILTER. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9986841 ↗
• MalfunctionApr 22, 2020Disconnection; Loose or Intermittent Connection; Connection Problem; Disconnection; Loose or Intermittent Connection; Connection Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE ONE-WAY VALVE TO A SMITHS MEDICAL PNEUPAC DISPOSABLE CIRCUIT BECAME DISCONNECTED. IT WAS REPORTED THAT THE CONNECTOR WAS EASILY DETACHED FROM THE PRODUCT FOLLOWING ATTACHING AN HME FILTER. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9986839 ↗
• MalfunctionApr 22, 2020Disconnection; Loose or Intermittent Connection; Connection Problem; Disconnection; Loose or Intermittent Connection; Connection Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE ONE-WAY VALVE TO A SMITHS MEDICAL PNEUPAC DISPOSABLE CIRCUIT BECAME DISCONNECTED. IT WAS REPORTED THAT THE CONNECTOR WAS EASILY DETACHED FROM THE PRODUCT FOLLOWING ATTACHING AN HME FILTER. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9986835 ↗