NA 8404BXRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04048551441930), received between Apr 24, 2025 and Aug 5, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Loose or Intermittent Connection; No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150329 ↗
• MalfunctionFeb 23, 2026No Display/Image

  IT WAS REPORTED THAT THERE IS A DIM LIGHT, IMAGE BLURRY. NO PATIENT INVOLVEMENT REPORTED. NO NEGATIVE IMPACT ON STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24415286 ↗
• MalfunctionNov 26, 2025Device Reprocessing Problem; No Display/Image; Poor Quality Image; Device Reprocessing Problem; No Display/Image; Poor Quality Image

  IT WAS REPORTED THAT "IMAGE LOSS" NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658869 ↗
• MalfunctionSep 19, 2025Leak/Splash; Poor Quality Image; Energy Output Problem; Leak/Splash; Poor Quality Image; Energy Output Problem

  IT WAS REPORTED THE DEVICE HAD FLICKERING LIGHT. NO PATIENT OR PROCEDURE INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23096395 ↗
• MalfunctionSep 18, 2025Device Reprocessing Problem; Electrical /Electronic Property Problem; Device Reprocessing Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THERE WAS A FAILURE OF THE C-MAC POCKET MONITOR DURING INTUBATION. NO FURTHER INFORMATION AVAILABLE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: -9610617-2025-01631. -9610617-2025-01330.

  Patient problems: Insufficient Information

  MAUDE report 23089756 ↗
• MalfunctionSep 18, 2025Device Reprocessing Problem; Electrical /Electronic Property Problem; Device Reprocessing Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THERE WAS A FAILURE OF THE C-MAC POCKET MONITOR DURING INTUBATION. NO FURTHER INFORMATION AVAILABLE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2025-01330, 9610617-2025-01632.

  Patient problems: Insufficient Information

  MAUDE report 23089755 ↗
• MalfunctionAug 21, 2025Device Reprocessing Problem; Electrical /Electronic Property Problem; Device Reprocessing Problem; Electrical /Electronic Property Problem

  THE FOLLOWING WAS REPORTED: LOOSE CONTACT VIDEO IMAGE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22866627 ↗
• MalfunctionAug 4, 2025Optical Problem; Optical Problem

  ACCORDING TO THE INFORMATION RECEIVED, LIGHT SOURCE WEAK. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22710133 ↗
• MalfunctionJul 15, 2025Optical Problem; Optical Problem

  ACCORDING TO THE INFORMATION RECEIVED, LIGHT WORKS, BUT NO PICTURE. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22516115 ↗
• MalfunctionApr 28, 2025Device Reprocessing Problem; Optical Problem; Device Reprocessing Problem; Optical Problem

  IT WAS REPORTED THAT THE DEVICE HAD DIMMED LIGHT. NO PATIENT OR PROCEDURE INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21918492 ↗
• MalfunctionApr 24, 2025Mechanical Problem; Output Problem; Mechanical Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS A LOOSE CONTACT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21905786 ↗