ISA OR+ 9685Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843997009317), received between Apr 8, 2022 and Apr 8, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Readings” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2022High Readings; High Readings

  THE CUSTOMER REPORTED THE ISA IS SHOWING 115% ETCO2 WHEN VENTILATOR SETTINGS IS AT 40% O2. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14060206 ↗
• MalfunctionApr 8, 2022High Readings; High Readings

  THE CUSTOMER REPORTED THE ISA IS SHOWING 115% ETCO2 WHEN VENTILATOR SETTINGS IS AT 40% O2. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14059877 ↗
• MalfunctionApr 8, 2022High Readings; High Readings

  THE CUSTOMER REPORTED THE ISA IS SHOWING 115% ETCO2 WHEN VENTILATOR SETTINGS IS AT 40% O2. NO CONSEQUENCES OR IMPACT TO PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14059782 ↗