C-MAC 11301BNXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551314609), received between Mar 9, 2023 and Mar 9, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2023No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE DEVICE FAILED DURING USE. UPON INSERTION INTO THE PATIENT'S TRACHEA, THE IMAGE WAS LOST ON THE C-MAC MONITOR. UPON WITHDRAWAL, THE IMAGE RETURNED. BUT THEN THE SAME FAILURE OCCURRED AGAIN. OR STUFF NEEDS TO SOURCE AN ALTERNATIVE SCOPE TO USE. THIS ADDED AN EXTENDED PERIOD TO THE PROCEDURE, APPARENTLY TURNING A PROCEDURE THAT SHOULD HAVE LASTED APPROXIMATELY THIRTY MINUTES INTO ONE THAT LASTED AN HOUR AND A HALF. NO INFORMATION ABOUT PATIENT HARM AND THE HAZARD SO FAR.

  Patient problems: Insufficient Information

  MAUDE report 16513707 ↗
• MalfunctionMar 9, 2023No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE DEVICE FAILED DURING USE. UPON INSERTION INTO THE PATIENT'S TRACHEA, THE IMAGE WAS LOST ON THE C-MAC MONITOR. UPON WITHDRAWAL, THE IMAGE RETURNED. BUT THEN THE SAME FAILURE OCCURRED AGAIN. OR STUFF NEEDS TO SOURCE AN ALTERNATIVE SCOPE TO USE. THIS ADDED AN EXTENDED PERIOD TO THE PROCEDURE, APPARENTLY TURNING A PROCEDURE THAT SHOULD HAVE LASTED APPROXIMATELY THIRTY MINUTES INTO ONE THAT LASTED AN HOUR AND A HALF. NO INFORMATION ABOUT PATIENT HARM AND THE HAZARD SO FAR.

  Patient problems: Insufficient Information

  MAUDE report 16513702 ↗