C-MAC 8403AXCRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04048551389478), received between May 11, 2025 and Sep 17, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Output 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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 17, 2026No Display/Image

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50812702 ↗
• MalfunctionJan 26, 2026Loss of or Failure to Bond; No Display/Image; Component Missing

  ACCORDING TO THE INFORMATION RECEIVED, A PATIENT WAS INTUBATED WITH THE C-MAC DEVICE AS PLANNED. THE DEVICE WAS USED WITHOUT ANY PROBLEMS EARLIER IN THE MORNING. THE DEVICE WAS THEN WASHED IN THE EQUIPMENT MAINTENANCE, AFTER WHICH IT WAS BROUGHT BACK TO THE ROOM TO BE CHARGED. THE DEVICE WAS SWITCHED ON AS NORMAL, AND THE POWER CORD WAS PLUGGED IN. THE IMAGE DISAPPEARED MOMENTARILY A FEW TIMES BUT RETURNED AS NORMAL. JUST BEFORE THE NEXT INTUBATION BEGAN, THE IMAGE ON THE VIDEO LARYNGOSCOPE BECAME VERY DARK, SO-CALLED NEGATIVE, I.E. THE COLORS WERE DARK AND PURPLE. THE DEVICE WAS UNUSABLE AT THAT TIME. IT WAS AN RSI INTUBATION. NO TIME TO CHANGE TO A NEW DEVICE. INTUBATED WITHOUT AN IMAGE LIKE A NORMAL LARYNGOSCOPE. AFTER THE SITUATION, THE DEVICE WAS RESTARTED, SO THE IMAGE WAS STILL UNUSABLE. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179414 ↗
• MalfunctionJun 23, 2025No Display/Image; Output Problem; Device Handling Problem; No Display/Image; Output Problem; Device Handling Problem

  IT WAS REPORTED THAT DURING THE PREPARATION PROCESS OF AN INTUBATION THE BLADE WAS NOT BEING RECOGNIZED. LIGHT COMES ON BUT IT DOESN'T SHOW UP ON THE CAMERA. THERE WAS NO SIGNIFICANT DELAY ONLY ABOUT 20 SECONDS TO OBTAIN THE DL EQUIPMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22311649 ↗
• MalfunctionMay 13, 2025Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED THAT COVER GLASS IS MISSING, BENT BLADE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22015285 ↗
• MalfunctionMay 11, 2025Device Reprocessing Problem; Output Problem; Device Reprocessing Problem; Output Problem

  IT WAS REPORTED THAT "LIGHT NOT WORKING, UPON RECEIPT NOTICED THAT COVER GLASS MISSING ON BLADES." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21999922 ↗
• MalfunctionMay 11, 2025Device Reprocessing Problem; Output Problem; Device Reprocessing Problem; Output Problem

  IT WAS REPORTED THAT "LIGHT NOT WORKING, UPON RECEIPT NOTICED THAT COVER GLASS MISSING ON BLADES." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21999917 ↗
• MalfunctionMay 11, 2025Device Reprocessing Problem; Output Problem; Device Reprocessing Problem; Output Problem

  IT WAS REPORTED THAT "LIGHT NOT WORKING, UPON RECEIPT NOTICED THAT COVER GLASS MISSING ON BLADES." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21999889 ↗