Sechrist Industries, Inc. 3500CP-GRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00899660002345), received between Feb 17, 2021 and Jan 8, 2026 — classified as 1 death, 10 malfunctions.

The most frequently reported specific device problem is “No Audible Alarm” (5 reports).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026No Audible Alarm

  CUSTOMER REPORTED THAT THE AIR AND OXYGEN ALARM NOT ACTIVE WHEN LOW PRESSURE. NO PATIENT INVOLVEMENT OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24010742 ↗
• MalfunctionDec 9, 2025No Flow; No Flow

  CUSTOMER REPORTED STAFF WAS ATTEMPTING TO OXYGENATE THE PATIENT WHILE HE/SHE WAS ON BYPASS AND WERE UNABLE TO. STAFF SWAPPED THE DEVICE FOR ANOTHER ONE AND IT WORKED APPROPRIATELY. NO PATIENT HARM OCCURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759634 ↗
• MalfunctionNov 24, 2025No Audible Alarm; No Audible Alarm

  CUSTOMER REPORTED THAT THE MIXER WON'T ALARM AND HAS A HISSING SOUND COMING FROM IT. NO PATIENT INVOLVEMENT OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638158 ↗
• MalfunctionOct 20, 2025Device Contamination with Body Fluid; Device Contamination with Body Fluid

  IT WAS REPORTED THAT BLOOD HAS ENTERED THE GAS MIXER. NO HARM TO ANY PERSON WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23342249 ↗
• MalfunctionJul 30, 2025Output Problem; Output Problem

  CUSTOMER REPORTING, "THE OXYGEN BLENDER WAS NOT PROVIDING 100% OXYGEN, AS IT WAS SET TO, BUT A MUCH LOWER FIO2." NO PATIENT INVOLVEMENT OR INJURY REPORTED. NO OTHER INFORMATION PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22670049 ↗
• MalfunctionJul 29, 2025No Audible Alarm; No Audible Alarm

  CUSTOMER REPORTED THE UNIT HAS NO ALARM WHEN ONE OF THE SUPPLY LINES IS MISSING. THIS ISSUE WAS DISCOVERED DURING SET-UP AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22654861 ↗
• MalfunctionApr 18, 2025No Audible Alarm; No Audible Alarm

  CUSTOMER REPORTED THE UNIT DOES NOT ALARM WHEN IT IS DISCONNECTED FROM AIR OR O2. NO PATIENT INCIDENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21868146 ↗
• MalfunctionJan 21, 2025Gas Output Problem; Gas Output Problem

  INCIDENT REPORTED TO SECHRIST BY EUROPEAN DISTRIBUTOR ON 12/20/2024. CUSTOMER REPORTING THAT THE MIXER WAS NOT DELIVERING GAS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21203726 ↗
• MalfunctionJan 15, 2025Device Contamination with Body Fluid; Device Contamination with Body Fluid

  CUSTOMER REPORTED THE DEVICE HAS BLOOD INSIDE, DURING AN ACCIDENTAL SITUATION THAT MAKES THE DEVICE UNFEASIBLE TO USE. NO PATIENT INJURY WAS REPORTED. THE DEVICE HAS BEEN DECOMMISSIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21160393 ↗
• MalfunctionOct 30, 2024No Audible Alarm; No Audible Alarm

  CUSTOMER IS REPORTING THAT THERE UNIT IS NOT ALARMING. NO PATIENT INVOLVEMENT OR INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20571712 ↗
• DeathFeb 17, 2021Infusion or Flow Problem; Infusion or Flow Problem

  THIS SUPPLEMENTAL REPORT IS REQUIRED TO REPORT DEVICE EVALUATION RESULTS. CORRECTION: D8

  Patient problems: Hypoxia

  MAUDE report 11340465 ↗