Oridion N85Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521172043), received between Nov 21, 2018 and Nov 21, 2024 — classified as 1 death, 4 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Use” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2024Failure to Calibrate; High Readings; Failure to Calibrate; High Readings

  ACCORDING TO THE REPORTER, THE DEVICE WAS UNABLE TO CALIBRATE AND GAVE A HIGH READINGS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20754167 ↗
• MalfunctionAug 10, 2022Temperature Problem; Temperature Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT BECAME HOT WHEN POWERED ON. THE DEVICE WAS POWER CYCLED FOR TROUBLESHOOTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15201567 ↗
• MalfunctionJan 14, 2022Device Damaged Prior to Use; Material Split, Cut or Torn; Device Damaged Prior to Use; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD A CRACK CASE NEAR TO POWER SWITCH AND PSU CABLE LOW VOLTAGE SIDE LOCKING TAB WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13260611 ↗
• DeathMar 13, 2019Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, THE DEVICE WAS CAUGHT ON FIRE WHICH ALLEGEDLY CAUSED BY THE DEFIBRILLATOR. IT WAS REPORTED THAT THE DEVICE WAS NOT POWERED ON AND WAS NOT CONNECTED TO THE PATIENT. THE DEVICE WAS BURNED/MELTED DUE TO FIRE FROM ELECTRICAL ENERGY ARC FROM DEFIBRILLATOR PAD AND HIGH FLOW OXYGEN FROM NASAL CANNULA IN PATIENT'S BED. THE CUSTOMER REPORTED THAT THE PATIENT HAD BURNS TO HEAD, NECK, FACE, EARS AND SHOULDERS DUE TO THE FIRE AND DIED DUE TO CARDIAC ARREST. THE CAUSE OF DEATH WAS NOT RELATED TO DEVICE.

  Patient problems: Death

  MAUDE report 8416857 ↗
• MalfunctionNov 21, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  ACCORDING TO THE REPORTER, THE UNIT WAS NOT REALLY USED ON A PATIENT. THERE WAS A CODE BLUE ON A PATIENT, THEY WERE GOING TO USE THIS UNIT ON THE PATIENT TO CHECK SPO2 AND CO2. BUT WHEN THE UNIT WAS TURNED ON, IT WAS RED AND DID NOT GIVE ANY KIND OF READINGS AT ALL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8095641 ↗