IntelliSpace Critical Care and Anesthesia CS770 IntelliSpace CC & Anesthesia UpgrRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884838093973), received between Oct 1, 2019 and Sep 11, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Computer Operating System Problem” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2020Inaccurate Delivery

  THE CUSTOMER REPORTED THAT THE REPORT MISCALCULATES THE AMOUNT OF DRUG INJECTED. THE DEVICE WAS NOT IN USE ON A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10522083 ↗
• MalfunctionMar 6, 2020Data Problem

  THE CUSTOMER ALLEGED WHEN A DOCTOR PRESCRIBES FENTANYL VIA TRANSDERMAL ROUTE (PATCH WITH THE FOLLOWING DOSAGE: 100 G/H) IN "DISCONTINUE ORDER" CATEGORY, IT IS NOT POSSIBLE TO CHOOSE A DOSE IN G/H. THUS, THE USER HAS TO WRITE THE DOSE CONTAINED IN THE PATCH WHICH IS NOT CLEAR BECAUSE FOR EXAMPLE HE WILL WRITE ¿16.8 MG¿ TO TRANSLATE ¿100 G/H DURING 72 H. NO ADVERSE EVENT INVOLVING PATIENT OR USER WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9797285 ↗
• MalfunctionOct 1, 2019Computer Operating System Problem

  THE CUSTOMER ALLEGED THAT THEY COULD NOT DISCONTINUE AN ORDER. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR PATIENT HARM. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9140625 ↗