IntelliSpace Perinatal IntelliSpace Perinatal K Large Arch.Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00884838084483), received between Apr 19, 2023 and Jun 23, 2026 — classified as 1 death, 11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 23, 2026Patient Data Problem

  PHILIPS RECEIVED A COMPLAINT ON AN INTELLISPACE PERINATAL K LARGE ARCH. INDICATING NAMES OF PATIENTS SHOW UP INCORRECTLY. IT IS UNKNOWN IF THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25592434 ↗
• MalfunctionJun 11, 2026No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON AN INTELLISPACE PERINATAL K LARGE ARCH INDICATING THAT THE PATIENT SOUND ALARMS DO NOT WORK. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE EVENT OR PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25469939 ↗
• MalfunctionJun 1, 2026Defective Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLISPACE PERINATAL K LARGE ARCH. INDICATING THAT THE NBP SYSTOLIC READINGS WERE NOT GENERATING ALARMS AT THE CENTRAL STATION. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT; THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25349503 ↗
• MalfunctionMay 12, 2026Device Alarm System

  PHILIPS RECEIVED A COMPLAINT ON AN INTELLISPACE PERINATAL K LARGE ARCH. INDICATING THAT THEY ARE NOT RECEIVING HEARTRATE ALARMS. THE DEVICE WAS IN USE ON A PATIENT AT TIME OF EVENT; THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25156625 ↗
• MalfunctionMar 4, 2026Device Alarm System

  PHILIPS RECEIVED A COMPLAINT ON AN INTELLISPACE PERINATAL K LARGE ARCH. INDICATING THAT THEY ARE NOT RECEIVING FETAL HEARTRATE ALARMS. IT WAS FURTHER CLARIFIED THAT THE STAFF WAS EXPECTING TACHYCARDIA AND BRADYCARDIA ALERTS TO BE INSTANTANEOUS AND THEY WANTED INFORMATION REGARDING ALARM LIMITS. THE DEVICE WAS IN USE ON A PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24511587 ↗
• MalfunctionFeb 6, 2026No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLISPACE PERINATAL K LARGE ARCH. INDICATING THAT ONE PC IS NOT AUDIBLY ALARMING. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24279045 ↗
• MalfunctionOct 24, 2024Defective Alarm; Defective Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLISPACE PERINATAL K LARGE ARCH. (ISP) INDICATING THAT DID NOT GET COINCIDENCE ALARMS FOR ABOUT TWO HOURS. THE DEVICE WAS IN CLINICAL USE AT THE TIME THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE VENT OR PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522341 ↗
• DeathMay 10, 2024No Audible Alarm; No Audible Alarm

  IT WAS REPORTED THE MONITORING SYSTEM HAS NO SOUND AND THE BABY PASSED AWAY BECAUSE THE MONITOR DID NOT SOUND. THE CUSTOMER INDICATED THE ALARM SYSTEM WAS INSTALLED CORRECTLY AND SOUNDS WHEN TESTING; HOWEVER, THE SYSTEM ONLY DISPLAYS AN ALARM ICON WITH AN X, NOT THE ACTUAL ALARMS. THE FIELD SERVICE ENGINEER (FSE) WENT ONSITE AND DISCOVERED THAT IT HAD RECENTLY CHANGED THE PC AND THE ALARM MODULE WAS NOT INSTALLED OR NOT INSTALLED CORRECTLY. PHILIPS HAD NOT BEEN MADE AWARE OF THIS CHANGE. BASED ON THIS INFORMATION, IT APPEARS THERE IS NOT A DEVICE MALFUNCTION; HOWEVER, THE INCORRECT INSTALLATION OF THE ALARM MODULE WAS DUE TO USE ERROR ON THE PART OF THE HOSPITAL IT DEPARTMENT WHICH CONTRIBUTED TO THE DEATH. THE FSE CONFIRMED THAT THE ALARM MODULE WAS INSTALLED IN THE CLIENT PC AND THE DEVICE WAS OPERATIONAL AFTER REPAIRS WERE COMPLETED.

  Patient problems: Insufficient Information

  MAUDE report 19288321 ↗
• MalfunctionMar 13, 2024No Audible Prompt/Feedback; No Audible Prompt/Feedback

  THE CUSTOMER REPORTED THAT THE STAFF HAS VISUALS ALARMS BUT UNABLE TO HEAR ALARMS. THE DEVICE WAS IN USE ON PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18896597 ↗
• MalfunctionJan 19, 2024No Audible Alarm; No Audible Alarm

  PHILIPS RECEIVED A COMPLAINT ON THE INTELLISPACE PERINATAL K LARGE ARCH. SN (B)(6) INDICATING WHEN THE FETAL MONITORING GOES OFF THERE IS NO AUDIBLE ALARM ONLY THE VISUAL ALARM. THE DEVICE WAS IN USE MONITORING A PATIENT AT THE TIME OF THE EVENT. NO ADVERSE EVENT INVOLVING A PATIENT OR USER WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18545999 ↗
• MalfunctionSep 27, 2023Defective Alarm; Defective Alarm

  IT WAS REPORTED THAT THE SYSTEM IS NOT ALARMING. THE DEVICE WAS IN USE AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17826251 ↗
• MalfunctionApr 19, 2023No Audible Alarm; No Audible Alarm

  THE CUSTOMER REPORTED THAT THEIR PATIENT MONITORING SYSTEM WAS NOT ALARMING. THE DEVICE WAS IN USE. THERE WAS NO REPORT OF ANY PATIENT OR USER HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770600 ↗