NA H.02Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00884838075153), received between Jan 22, 2018 and Feb 10, 2021 — classified as 3 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Computer Operating System Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2021Application Program Problem: Medication Error

  THE CUSTOMER ALLEGED "IN (B)(6) WE HAVE AN ISSUE THAT SOMETIMES THE PATIENT MEDICATION INFOGRID IS NOT FILLED CORRECTLY." NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11307863 ↗
• MalfunctionDec 28, 2020Display or Visual Feedback Problem; Insufficient Flow or Under Infusion

  THE CUSTOMER REPORTING AN ERROR CONCERNING INFUSION PUMP MANAGEMENT . DOCUMENTATION SHOWS THE PATIENT RECEIVED LESS OF A DOSE THAN THEY SHOULD HAVE WHICH COULD HAVE CAUSED HARM TO THE PATIENT OR OTHER PATIENTS. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077692 ↗
• MalfunctionNov 17, 2020Data Problem

  THE CUSTOMER ALLEGED "DATA FROM SILICON (PHARMACY MEDICATION) ARE NOT BEING TRANSFERRED". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10857428 ↗
• MalfunctionOct 29, 2020Device Sensing Problem

  THE CUSTOMER REPORTED THAT THE ANESTHESIA LOG CANNOT BE DETECTED. 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 10755756 ↗
• MalfunctionOct 26, 2020Improper or Incorrect Procedure or Method

  THE CUSTOMER REPORTED A DRUG ERROR TO MRC (#0116281159) . A PATIENT RECEIVED A DOUBLE DOSE OF THE ANTIVIRAL DRUG¿AMIKACIN¿ DUE TO A WORKFLOW ERROR. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10734329 ↗
• MalfunctionOct 8, 2020Computer Operating System Problem

  CUSTOMER REPORTED THAT DRUGS DISAPPEARED FROM THE MAR AFTER PLACING THE ORDERS AND THEN REAPPEARED AS "PENDING" ORDERS. THE DEVICE WAS IN USE ON A PATIENT. THERE WAS NO REPORT OF PATIENT OR USER HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10648849 ↗
• MalfunctionAug 13, 2020Protective Measures Problem

  THE CUSTOMER ALLEGED "RUN RATE DEXMEDOTOMIDIN NOT TRANSFERRED". THE DEVICE WAS NOT IN USE ON A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 10403344 ↗
• MalfunctionJun 11, 2020Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER ALLEGED THAT A PATIENT USING PRESCRIBED DRUG EPINEPHRINE WAS ASSIGNED "INFUSING 18 ML / H AND AFTER A WHILE THE PATIENT DE-ALLOCATES HIMSELF AND THEN APPEARS AS A PROPOSAL FOR NOREPINEPHRINE, WHICH ALREADY HAS [PATIENT] PUMP". THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10145680 ↗
• MalfunctionMar 2, 2020Data Problem

  THE CUSTOMER ALLEGED "PHARMACY DATA ARE NOT TRANSFERRED". THE DEVICE WAS NOT IN USE ON A PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9777737 ↗
• MalfunctionFeb 19, 2020Image Display Error/Artifact

  THE CUSTOMER ALLEGED DRUG FIELD FOR OUTPATIENT PRESCRIPTIONS IS NOT GREYED OUT ANYMORE. NO ADVERSE EVENT INVOLVING PATIENT OR USER WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9726313 ↗
• MalfunctionFeb 10, 2020Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER ALLEGED "IT HAS BEEN REPORTED AGAIN THAT THE CALORIES ARE NOT CALCULATED CORRECTLY BY PROPOFOL". NO ADVERSE EVENT INVOLVING PATIENT OR USER WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9688208 ↗
• MalfunctionJan 23, 2020Output Problem

  THE CUSTOMER ALLEGED "NO MEDICATION WAS TRANSFERRED FROM A SILICON PATIENT TO INTELLISPACE CRITICAL CARE AND ANESTHESIA (ICCA)". 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 9624993 ↗
• MalfunctionJan 13, 2020Inaccurate Synchronization

  THE CUSTOMER ALLEGED "DISCONTINUE DRUG ¿LEVOFLOXACIN¿ BUT NOT SYNCHRONIZED TO INTELLISPACE CRITICAL CARE AND ANESTHESIA (ICCA)".THE DEVICE WAS NOT IN USE ON A PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9582607 ↗
• MalfunctionDec 9, 2019Patient Data Problem

  THE CUSTOMER ALLEGED CALCULATIONS WERE NOT FUNCTIONING. ALL THE PATIENTS RECORDS ON INTELLISPACE CRITICAL CARE AND ANESTHESIA (ICCA) FROM 21/11/2019 UNTIL THE ICCA SERVER RESTART ON 25/11/2019 WERE AFFECTED. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9440881 ↗
• MalfunctionNov 22, 2019Computer Operating System Problem

  THE CUSTOMER ALLEGED OUT PATIENTS ORDERING SYSTEM ISSUE ¿ IT DOES NOT COPY THE PRESCRIPTION AS REV H DID, IT CREATES AN ORDER FOR EVERYTHING WITH SEARCH CRITERIA IN IT. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9363406 ↗
• MalfunctionNov 22, 2019Application Program Problem: Medication Error

  THE CUSTOMER ALLEGED CURRENTLY, NURSING STAFF ARE ABLE TO ADMINISTER MEDICATIONS ABOVE THE PRESCRIBED DOSE WITH NO WARNING. NO ADVERSE EVENT OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9363131 ↗
• MalfunctionNov 18, 2019Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER ALLEGED THAT THE INCORRECT AMOUNT OF DRUG "ELOMEL" WAS VISIBLE IN THE MEDICAL ADMINISTRATION REPORT (MAR) AND ON FLOWSHEET. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. NO ADVERSE EVENT OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9334800 ↗
• MalfunctionNov 14, 2019Protective Measures Problem

  THE CUSTOMER ALLEGED THAT THE DOCTOR WENT TO PRESCRIBE A MEDICATION ¿MYCOPHENOLATE¿. WHEN HE COULD NOT FIND THE MEDICATION IN THE INTELLISPACE CRITICAL CARE AND ANESTHESIA (ICCA) SYSTEM, HE PRESCRIBED IT UNDER ¿VARIOUS INSTRUCTIONS¿. DUE TO THIS, MYCOPHENOLATE DID NOT APPEAR ON THE FLOWSHEET (MAR) AND THE MEDICATION WAS NOT GIVEN FOR 2 DAYS. THE CUSTOMER NOTED THAT ONLY DRUGS PRESCRIBED UNDER "MEDICATIONS" ARE SHOWN ON THE FLOWSHEET. NO ADVERSE EVENT OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9321810 ↗
• MalfunctionNov 13, 2019Appropriate Device Problem Term/Code Not Available

  THE CUSTOMER ALLEGED "THE PRESCRIPTION SEEMS TO BE TRUNCATED, BUT THIS DOESN¿T AFFECT ANY OF THE OTHER PRESCRIPTIONS". THERE WAS NO REPORT OF ANY ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9316622 ↗
• MalfunctionNov 13, 2019Missing Information

  THE CUSTOMER ALLEGED TRUNCATION HIDES IMPORTANT BITS OF INFORMATION. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR PATIENT HARM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9316171 ↗
• MalfunctionOct 6, 2019Data Problem

  THE CUSTOMER ALLEGED THAT THE DOCTOR WAS UNABLE TO SAVE PRESCRIPTIONS AFTER ENTERING THE PRESCRIPTIONS IN THE DATABASE. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9160276 ↗
• MalfunctionAug 7, 2019Computer Operating System Problem

  THE CUSTOMER ALLEGED THAT THE ORDER PREVIEW FOR PEDIATRICS DID NOT WORK. ORDERS DID NOT ARRIVE FROM (B)(6). THERE WAS NO REPORT OF ANY ADVERSE EVENT OR PATIENT HARM. THE DEVICE WAS NOT IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8871262 ↗
• MalfunctionAug 2, 2019Computer Operating System Problem

  THE CUSTOMER ALLEGED THEY WERE UNABLE TO CANCEL THE ORDER AFTER THEY MISTAKENLY RECORDED A FUTURE INTAKE. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8856461 ↗
• InjuryJul 11, 2019Adverse Event Without Identified Device or Use Problem

  A PATIENT RECEIVED INAPPROPRIATE MEDICATION ORDER DURING CUSTOMER INTELLISPACE CRITICAL CARE AND ANESTHESIA (ICCA) TRAINING SESSION. IT WAS STATED THAT THE PHILIPS CLINICAL SPECIALIST WAS SHOWING HOW TO PLACE AN ORDER IN ICCA AND THOUGHT SHE WAS ON A TEST PATIENT AND PLACED THE ORDER ON A REAL PATIENT AND THE PATIENT RECEIVED THE DRUG. THEY ALLEGE THAT THE PATIENT RECEIVED MEDICATION THAT WAS INCOMPATIBLE WITH HIS STATE OF HEALTH AND ENDANGERED HIS LIFE. . IT WAS REPORTED THAT PATIENT EXPERIENCED HARM. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER NO NEW INFORMATION CONCERNING HOW THE PATIENT WAS HARMED WAS RECEIVED.

  Patient problems: Injury

  MAUDE report 8779842 ↗
• MalfunctionJul 2, 2019Measurement System Incompatibility

  THE CUSTOMER REPORTED THAT THEY ATTEMPTED TO CHANGE THE UNITS OF MEASURE FROM DOSE(S) TO PACK(S)" HOWEVER THE UNITS OF MEASURE COULD NOT BE CHANGED. THERE WAS NO REPORT OF ANY PATIENT OR USER 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 8752189 ↗