Shiley 86445Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 30884522005719), received between Oct 8, 2019 and Feb 4, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 4, 2025Use of Device Problem; Material Split, Cut or Torn; Use of Device Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT A CIRCUIT DISCONNECTION ALARMED ON THE VENTILATOR AND THE BIOMEDICAL ENGINEER CAME AND PERFORMED THE CORRESPONDING REVISIONS OF THE EQUIPMENT, WALL, OUTLETS, FILTERS AND PATIENT CIRCUIT. ALTHOUGH NO FLAWS WAS DETECTED, THE DECISION WAS MADE TO CHANGED THE VENTILATOR. WHEN THE PATIENT WAS RECONNECTED TO THE VENTILATOR, THE PROBLEM PERSISTED AND THE CONDITION OF THE ENDOTRACHEAL TUBE WAS CHECKED. IT WAS DETECTED THAT IT WAS DEFLATED AND ONCE INFLATED THE EQUIPMENT STOPPED ALARMING. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21309618 ↗
• MalfunctionAug 22, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  "ACCORDING TO THE REPORTER, DURING USE, A CIRCUIT DISCONNECTION ALARM WAS HEARD ON THE VENTILATOR. CORRESPONDING CHECKS WERE PERFORMED ON THE VENTILATOR, WALL OUTLETS, FILTERS, AND PATIENT CIRCUIT, AND NO FLAWS WERE DETECTED. WHEN THE PATIENT WAS REINSTALLED ON NEW EQUIPMENT, THE PROBLEM PERSISTED. THE CONDITION OF THE ENDOTRACHEAL TUBE WAS CHECKED AND IT WAS FOUND TO BE DEFLATED. THE TUBE WAS INFLATED, AND THE EQUIPMENT STOPPED ALARMING. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20039992 ↗
• MalfunctionMar 4, 2024Use of Device Problem; Appropriate Device Problem Term/Code Not Available; Use of Device Problem; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, FOR THE 4.5-MM TUBE SIZE, THE BALLOON WAS SMALL ENOUGH TO PASS BACK THROUGH THE VOCAL CORDS AFTER DEFLATING. THERE WAS NO REPORTED PATIENT OUTCOME.

  Patient problems: Insufficient Information

  MAUDE report 18830962 ↗
• MalfunctionDec 14, 2023Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, THE PILOT BALLOON FELL OFF AT THE END OF THE ENDOTRACHEAL TUBE AFTER INTUBATION. THE PATIENT WAS EXTUBATED, AND A NEW ENDOTRACHEAL TUBE WAS INSERTED.

  Patient problems: Unintended Extubation

  MAUDE report 18332353 ↗
• InjuryJul 22, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, WHEN INTUBATING A PATIENT IT WAS OBSERVED THAT THE DEVICE¿S PIPE TUBE 4.5 HAD INFLATION/DEFLATION ISSUE. IT WAS EXCHANGED FOR ANOTHER AND IT HAPPENED THE SAME. PATIENT WAS REINTUBATED WITH 5.0 TUBE.

  Patient problems: Extubate

  MAUDE report 10310953 ↗
• InjuryJul 22, 2020Use of Device Problem; Use of Device Problem

  ACCORDING TO THE REPORTER, WHEN INTUBATING A PATIENT IT WAS OBSERVED THAT THE DEVICE¿S PIPE TUBE 4.5 HAD INFLATION/DEFLATION ISSUE. IT WAS EXCHANGED FOR ANOTHER AND IT HAPPENED THE SAME. PATIENT WAS REINTUBATED WITH 5.0 TUBE.

  Patient problems: Extubate

  MAUDE report 10308223 ↗
• MalfunctionOct 8, 2019Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE UNIT'S TUBE PARTS WERE APART. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9165681 ↗