Shiley 76275Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 40884521157409), received between Nov 5, 2020 and Jan 12, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Disconnection” (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 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.

• MalfunctionJan 12, 2022Use of Device Problem; Gas/Air Leak; Use of Device Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, THE CUFF HAD AN INFLATION/DEFLATION ISSUE. THERE WAS A LEAK FOUND. THERE IS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13236715 ↗
• MalfunctionDec 28, 2020Disconnection; Material Integrity Problem; Disconnection; Material Integrity Problem

  ACCORDING TO THE REPORTER, WHILE PREPARING FOR INTUBATION, THE CONNECTOR WAS FLOATING IN THE PACKAGE RATHER THAN BEING INTACT AND CONNECTED. ATTEMPTED TO REPLACED THE CONNECTOR HOWEVER IT WAS TOO LOOSE AND KEPT FALLING OUT AND WOULD NOT HOLD CONNECTION ON THE 7.5. ANOTHER TUBE WAS REPLACED TO ISOLATE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077694 ↗
• MalfunctionDec 28, 2020Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE UNIT CONNECTOR ON CUFF IS FALLING OFF AND DID NOT HOLD CONNECTION. THE CUSTOMER STATED THEY ATTEMPTED TO REPLACE THE CONNECTOR HOWEVER IT WAS LOOSE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11074998 ↗
• MalfunctionDec 28, 2020Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE ANESTHESIA REGISTERED NURSE WAS PREPARING FOR INTUBATION AND NOTICED THAT THE CONNECTOR WAS FLOATING IN THE PRODUCT PACKAGE RATHER THAN BEING INTACT AND CONNECTED. THEY ATTEMPTED TO REPLACE THE CONNECTOR HOWEVER, IT WAS TOO LOOSE AND KEPT FALLING OUT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11074902 ↗
• MalfunctionNov 5, 2020Disconnection; Disconnection

  ACCORDING TO THE REPORTER, THE CONNECTOR ON THE CUFF IS FALLING OFF AND WILL NOT HOLD ITS CONNECTION ON THE 7.5. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10797329 ↗