CARDINAL HEALTH SEN48HNGSIRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10885425401666), received between Jan 25, 2024 and Jan 25, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Fire” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 25, 2024Fire; Fire

  THERE WAS A FIRE IN THE OPERATING ROOM AT THE HOSPITAL DURING A BLEPHAROPLASTY CASE BEING DONE BY ONE OF THE ENT SURGEONS. THE SURGEON WAS USING CAUTERY WHEN THE DRAPE IGNITED. THE PATIENT HAD MONITORED ANESTHESIA CARE, AND THE PROVIDER WAS USING A MASK TO DELIVER OXYGEN. THE FIRE TRIANGLE IS BEING INVESTIGATED BY THE CUSTOMER BETWEEN THE DRAPE, OXYGEN IN THE MASK AND THE CAUTERY AS IF THERE WAS TENTING THAT INVOLVED THE DRAPE. THE PATIENT ENDED UP WITH SECOND DEGREE BURNS AND WAS INTUBATED OVERNIGHT AND RELEASED IN THE FOLLOWING MORNING.

  Patient problems: Burn(s)

  MAUDE report 18582493 ↗