IntelliSpace Critical Care and Anesthesia Intellispace CC & AnesthesiaRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00884838085565), received between Jun 6, 2019 and May 5, 2026 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Application Program Problem: Medication Error” (4 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Device Handling Problem

  IT WAS REPORTED THAT IT IS DIFFICULT TO CHART ALLERGY IN ICCA AND MOREOVER THE DISPLAY IS TRUNCATED. IF THERE ARE SEVERAL ALLERGIES DOCUMENTED, IT DISPLAYS 3 DOTS BUT NOT ALL THE CONTENT. IN CONFIGURATION, ALLERGY INTERVENTION IS HARDCODED AND THERE IS NO POSSIBILITY TO ADD ALLERGY AND INTOLERANCE WITH DIFFERENT DOCUMENTATION INSIDE. A PATIENT'S PLANNED SURGERY WAS CANCELLED AND RESCHEDULED DUE TO THE FACT THAT A LATEX ALLERGY WAS NOT SEEN (DISPLAY TRUNCATED). NO ACTUAL HARM IS REPORTED HOWEVER, AN ADVERSE EVENT FOR PATIENT IS DESCRIBED AS A TYPE OF HARM. LATER, IT WAS CONFIRMED THAT THERE WAS NO HARM TO THE PATIENT. MEDICAL ATTENTION AND PREVENTIVE MEDICAL ATTENTION BOTH ARE MARKED AS YES BUT INFORMATION ABOUT MEDICAL CONDITION WAS NOT PROVIDED. GOOD FAITH EFFORTS WERE MADE TO GET MORE INFORMATION ABOUT MEDICAL ATTENTION AND PREVENTIVE MEDICAL ATTENTION, BUT FURTHER INFORMATION COULD NOT BE RECEIVED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 25084157 ↗
• InjuryMay 5, 2026Device Handling Problem

  IT WAS REPORTED THAT ALLERGY INTERVENTION IS HARD CODED IN ICCA. THERE IS NO POSSIBILITY TO INSERT ALLERGY AND INTOLERANCE WITH DIFFERENT DOCUMENTATION INSIDE. THE CUSTOMER IS NOT HAPPY WITH IT BECAUSE IT IS TOO COMPLEX TO FILL. IT IS ALSO MENTIONED THAT, IT CANNOT BE REPLACED IN PATIENT CHART BY AN OTHER INTERVENTION. IF USER FILL ANOTHER INTERVENTION (WITHOUT REMINDERS), THE CRITICAL INFORMATION OF ALLERGY WOULD NOT BE SEEN. THOUGH PATIENT HARM IS NOT REPORTED, ANAPHYLACTIC SHOCK IS PROVIDED AS IMPACT TO THE PATIENT. AN ATTEMPT HAS BEEN MADE TO CONFIRM THE IMPACT TO THE PATIENT BUT NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 25083979 ↗
• MalfunctionAug 23, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT ICCA HAS AN INTAKE MISCALCULATION ISSUE. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17603210 ↗
• InjuryJun 13, 2023Application Program Problem: Medication Error; Application Program Problem: Medication Error

  THE CUSTOMER REPORTED THAT THE INTELLISPACE CC & ANESTHESIA INDICATING THAT PRESCRIPTION ON ICCA SOFTWARE ON 21/04 OF LEVOFLOXACIN DOES NOT APPEAR IN THE NURSING CARE PLAN. THE DEVICE WAS IN USE AT TIME OF EVENT, AN ADVERSE EVENT WAS REPORTED.

  Patient problems: Drug Resistant Bacterial Infection

  MAUDE report 17119978 ↗
• MalfunctionMay 22, 2023Labelling, Instructions for Use or Training Problem; Application Program Problem: Medication Error; Labelling, Instructions for Use or Training Problem; Application Program Problem: Medication Error

  THE CUSTOMER REPORTED THAT SOME TIME SCHEDULES DID NOT DISPLAY ON PIPE/TAZO ORDER, SO THE PATIENT DIDN'T RECEIVE THE DRUG WHEN IT SHOULD HAVE BEEN. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16974701 ↗
• MalfunctionMay 17, 2023Data Problem; Data Problem

  THE CUSTOMER REPORTED THAT THE NURSE AT THE BEDSIDE DID NOT AUTOMATICALLY SEE PRESCRIBED MEDICATION. THEREFORE, PRESCRIBED SCHEDULES CAN POTENTIALLY BE MISSED. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950199 ↗
• MalfunctionMay 17, 2023Data Problem; Data Problem

  THE CUSTOMER REPORTED THAT WHEN A USER SAVES DATA FOR A GIVEN PATIENT, THE UPDATE DOES NOT PUSH ALL OTHER CLIENTS WHO HAVE THE RECORD OPEN; THE CLINICAL TEAMS DO NOT HAVE THE THE LATEST DATA AVAILABLE AT THE BED SPACE. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16950196 ↗
• MalfunctionApr 29, 2023Failure to Read Input Signal; Failure to Read Input Signal

  PHILIPS RECEIVED A COMPLAINT ON INTELLISPACE CC & ANESTHESIA INDICATING THATIM961311 DOES NOT ALLOW TO ASSIGN THE PERFUSIONS THAT THEY HAVE SCHEDULED AND ASSIGNS PERFUSIONS THAT THEY HAVE NOT HAD SCHEDULED. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16841140 ↗
• MalfunctionApr 26, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE ICCA DRUG CHART WAS MISSING SCHEDULED MEDICATIONS, RESULTING IN MISSED DOSES FOR CRITICAL MEDICATIONS. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16820825 ↗
• MalfunctionFeb 22, 2023Inaccurate Delivery; Inaccurate Delivery

  THE CUSTOMER REPORTED THAT FOR BED 7 IP-003 AND IP-015, INCORRECT VOLUME WAS INFUSED. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED. A PHILIPS REMOTE SERVICE ENGINEER (RSE) SPOKE TO THE CUSTOMER. THE RSE FOUND THERE WERE TWO PUMPS THAT ENCOUNTERED MULTIPLE DISCONNECTION ISSUES; IP-015 FROM 20 FEB 2023 2350H TO 21 FEB 2023 0306H(LOCATED AT CHANNEL 4), WHICH WAS THEN REPLACED BY IP-003(FROM CHANNEL 2 TO CHANNEL 4). ASIDE FROM THE MULTIPLE DISCONNECTIONS, THE RSE ALSO DETECTED A ¿RESET OF TOTAL INFUSED VOLUME¿ SIX TIMES BETWEEN 2350H TO 0943H (PLUS THE PUMP REPLACEMENT AT 0306H AND THE PUMP RE-ASSIGNMENT AFTER FLUID LABEL CHANGE). THE RSE INFORMED THE NURSE TO HELP TO MONITOR THE ISSUE, AND ASKED THE NURSE TO TRY AND SWAP THE LINK BRIDGE CURRENTLY IN USE BY IP-003 IN CASE THE ISSUE HAPPENS AGAIN FOR TROUBLESHOOTING/ISOLATION PURPOSES. IF THE ISSUE PERSISTS AFTER REPLACING/SWAPPING THE LINK BRIDGE, THE RSE WILL PROCEED TO REQUEST AN LINK BRIDGE (EC80) REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16417756 ↗
• MalfunctionFeb 17, 2023Application Program Problem: Medication Error; Application Program Problem: Medication Error

  PHILIPS RECEIVED A COMPLAINT BY THE CUSTOMER ON INTELLISPACE CC & ANESTHESIA INDICATING INCORRECT SPEED DUMP. IT GOES AT A SPEED OF 1ML/H AND IN THE ICCA IT SHOWS 40ML/H. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16396746 ↗
• MalfunctionJan 19, 2023Incorrect, Inadequate or Imprecise Result or Readings; Infusion or Flow Problem; Incorrect, Inadequate or Imprecise Result or Readings; Infusion or Flow Problem

  THE CUSTOMER REPORTED THAT THE FLUID MANAGEMENT IN ANESTHESIA IS NOT CORRECTLY ASSIGNED. ROOM 1 AND ROOM 9 SEEM TO BE SWAPPED. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED. A PHILIPS REMOTE SERVICE ENGINEER (RSE) REMOTELY CONNECTED TO THE CONTROL CENTER AT THE CUSTOMER SITE AND DETERMINED THE INFUSION PUMPS WOULD REQUIRE CONNECTION VIA THE PATIENT INFORMATION CENTER IX (PIIC IX). THE DEVICE REMAINS AT THE CUSTOMER SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16205613 ↗
• MalfunctionMay 6, 2020Application Program Problem: Medication Error

  THE CUSTOMER ALLEGED ¿LEVEL OF THE DRUG CIRCUIT FOR THE SYRINGE PUMP RELAYS: TRACEABILITY OF ERRONEOUS ADMINISTRATION WITH INCORRECT VALUES OF SPEED OR NAME OF DRUGS USED TOTALLY WRONG". THE DEVICE WAS NOT IN USE ON A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10029565 ↗
• MalfunctionNov 22, 2019Device Displays Incorrect Message

  THE CUSTOMER IS REPORTING THAT A MEDICATION WAS INCORRECTLY DISPLAYING 'OVERDUE' IN THE MAR. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9362255 ↗
• MalfunctionOct 17, 2019Output Problem

  THE CUSTOMER ALLEGED LAB REQUESTS HAVE NOT BEEN PRINTING. NO ADVERSE EVENT OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9204422 ↗
• MalfunctionOct 17, 2019Output Problem

  THE CUSTOMER ALLEGED LAB REQUESTS HAVE NOT BEEN PRINTING. NO ADVERSE EVENT OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9204305 ↗
• MalfunctionJul 10, 2019Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER ALLEGED END OF 2018 THE PROPERTY ¿ROUTE¿ WAS REMOVED FROM THE INTERVENTIONS. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8775149 ↗
• MalfunctionJun 6, 2019Patient Data Problem

  THE CUSTOMER ALLEGED A PRESCRIPTION IS NOT DISPLAYED AFTER SAVING, BUT IS PRESENT, AND ONLY VISIBLE AFTER ANOTHER LOGIN. THE DEVICE WAS IN USE ON A PATIENT AND THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8674671 ↗