Oridion RS08251Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521520875), received between Jun 16, 2017 and Feb 18, 2019 — classified as 2 malfunctions.

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

1 other recall cover devices cleared under the same FDA submission (K123690); they may or may not involve this specific model.

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.

• MalfunctionFeb 18, 2019Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE REPORTER, THE UNIT HAD NO AUDIO. IT WAS ALSO STATED THAT THE DEVICE'S SPEAKER IS NOT WORKING. THE SPEAKER ICON IS TURNED ON, HOWEVER NO ALARMS HEARD. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8347747 ↗
• MalfunctionJun 16, 2017No Audible Alarm; No Audible Alarm

  MEDTRONIC RECEIVED A REPORT THAT THE UNIT DID NOT HAVE AUDIO AFTER POWERING ON . IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 6647242 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123690. One submission often covers many models, so check the product and lot details in each record.

• Z-1577-2016 · Apr 13, 2016 · Terminated
  Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor, Battery Packs Model Number - 016400, 010520. Battery Pack used with the Capnostream"20 and Capnostrea