Capnostream20p DLCS08651-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521771697), received between Jan 4, 2022 and Sep 5, 2025 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 5, 2025Temperature Problem; Temperature Problem

  AN INCIDENT WAS REPORTED INVOLVING A UNIT EXPERIENCING INTERNAL COMPONENT ISSUES. THE UNIT EMITTED A SMOKE SMELL, INDICATIVE OF A BURNING INTERNAL COMPONENT, AND WAS FUNCTIONING INTERMITTENTLY. ADDITIONALLY, THE POWER CORD WAS FOUND TO BE DISCONNECTED FROM THE UNIT, FAILING TO ESTABLISH A PROPER CONNECTION. AS PART OF TROUBLESHOOTING, THE UNIT WAS TURNED OFF TO PREVENT FURTHER COMPLICATIONS. NO VISIBLE SMOKE WAS OBSERVED, AND NO POWER SURGE OCCURRED DURING THE EVENT. NO PATIENT WAS INVOLVED IN THE INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22975340 ↗
• MalfunctionAug 21, 2025Device Alarm System; Display or Visual Feedback Problem; Failure to Power Up; Manufacturing, Packaging or Shipping Problem; Device Alarm System; Display or Visual Feedback Problem; Failure to Power Up; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT, PRIOR TO USE, THE MONITOR FAILED TO FULLY POWER ON. THE SCREEN DID NOT DISPLAY ANY IMAGES, AND ONLY ONE AMBER LIGHT TURNED ON. THE MONITOR DID NOT PRODUCE ANY ALARMING SOUNDS. IT WAS POWER CYCLED, AND A NEW BATTERY WAS USED TO ISOLATE THE FAILURE. THIS WAS AN OUT-OF-BOX FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860657 ↗
• MalfunctionMar 19, 2022Device Alarm System; Device Damaged Prior to Use; Connection Problem; Device Alarm System; Device Damaged Prior to Use; Connection Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT HAD A LOOSE SPO2 CONNECTOR AND A BROKEN GAS PORT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13825069 ↗
• MalfunctionJan 4, 2022Failure to Power Up; Temperature Problem; Failure to Power Up; Temperature Problem

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT WOULD NOT POWER ON. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THERE WAS A BURNT SMELL. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13150561 ↗

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