RHINOFORCE 456802BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04048551164372), received between Aug 4, 2022 and Aug 8, 2022 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Optical Problem” (1 report).

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

• DeathAug 8, 2022Optical Problem; Optical Problem

  CUSTOMER REPORTED THAT DURING A PEDIATRIC ARREST OF A 4-YEAR-OLD, THE CAMERA WORKED, BUT THERE WAS NO LIGHT. THEY WERE ABLE TO SECURE THE AIRWAY WITH AN IGEL, BUT SADLY, THE CHILD DID NOT MAKE IT FOR REASONS THAT WERE BEYOND THE AIRWAY. THE CUSTOMER INDICATED THAT THE FAILURE OF THE C-MAC S PEDIATRIC IMAGER HAD NO BEARING ON THE PATIENT OUTCOME, AS THE PATIENT HAD SUSTAINED CRUSH INJURIES AND WOULD NOT HAVE SURVIVED.

  Patient problems: Cardiac Arrest; Crushing Injury

  MAUDE report 15182761 ↗
• InjuryAug 4, 2022Separation Problem; Separation Problem

  AS PER A MANUFACTURER INCIDENT REPORT #(B)(4) RECEIVED FROM THE FACTORY IN GERMANY: THE EVENT OCCURRED IN GERMANY. DURING PROCEDURE, THE JAW CAME OFF AND WAS SWALLOWED BY THE PATIENT. THE FRAGMENT WAS VISIBLE ON X-RAY, BUT AFTER A NEW X-RAY, IT WAS NOT VISIBLE ANYMORE. THEREFORE, IT IS UNCLEAR IF THE FRAGMENT REMAINED IN THE PATIENT'S BODY OR NOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15164664 ↗