BONSAI OM-812Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814470020037), received between Sep 29, 2017 and Sep 29, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionSep 29, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE INITIAL REPORTER CLAIMED THAT THE PATIENT CAME IN TO THE OFFICE FOR A VISIT AND WAS SEATED IN THE WAITING ROOM WITH THE UNIT ON. THE PATIENT SUDDENLY STARTED SLUMPING AND PASSED OUT. THE PARAMEDICS WERE THEN CALLED AND TRANSPORTED THE PATIENT TO THE HOSPITAL. THE INITIAL REPORTER CLAIMED THAT THE UNIT WAS DEFECTIVE, BLOWING OUT CONTINUOUS ON ITS OWN. A FOLLOW-UP INTERVIEW WITH THE INITIAL REPORTER REVEALED THAT UNIT WAS SET TO THE PATIENT'S PRESCRIPTION OF 2 LITERS OF OXYGEN PER MINUTE ON CONSERVE MODE. HE ALSO EXPLAINED THE UNIT WAS ATTACHED TO A CYLINDER AND TESTED BY A SERVICE TECHNICIAN WHO DISCOVERED THE UNIT WAS BLOWING CONTINUOUSLY ON CONSERVE MODE. NO INFORMATION WAS AVAILABLE OR PROVIDED REGARDING THE PATIENT'S MEDICAL BACKGROUND NOR THE HOSPITAL DISPOSITION.

  Patient problems: Fainting

  MAUDE report 6905811 ↗