IntelliSpace Event Management 11.03Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884838031746), received between Jan 24, 2018 and May 30, 2024 — classified as 3 deaths, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Defective Alarm” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 30, 2024Defective Alarm; Communication or Transmission Problem; Defective Alarm; Communication or Transmission Problem

  THE CUSTOMER REPORTED THAT THERE WAS NO RED ALARM ON CENTRAL MONITORING. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT, AND THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19425278 ↗
• InjurySep 12, 2022Delayed Alarm; Delayed Alarm

  IT WAS REPORTED THAT THERE WAS A DELAY IN RECEIVING THE ALERT FOR AN ASYSTOLE ALARM FROM THE INTELLISPACE EVENT MANAGEMENT (IEM) SYSTEM AND, AS A RESULT, THE PATIENT HAD EXPERIENCED AN ADVERSE EVENT AND IT WAS NECESSARY TO TRANSFER THE PATIENT TO THE INTENSIVE CARE UNIT (ICU).

  Patient problems: Asystole

  MAUDE report 15403156 ↗
• DeathFeb 24, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  HOLD SMP 2.24IT WAS REPORTED THAT ALARMS WERE NOT PAGED FOR BED 09B ON (B)(6) 2022 BETWEEN 06:45 AND 19:00 RESULTING IN A PATIENT DEATH.

  Patient problems: Asystole

  MAUDE report 13591204 ↗
• DeathSep 26, 2019Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT THEY NEED ACTIVITY LOG FOR (B)(6) 2019 AT 10:06AM FOR BED RM 334 TELE-V-FIB/TACH, DUE TO A RECENT PAGING ISSUE RELATED TO TELEMETRY ALERTS WITH THE EMERGIN (IEM) PAGING SYSTEM (PART 865206). THE SITE RELIES ON THE PHILIPS IEM PAGING AND VOCERA PHONE SYSTEM FOR PRIMARY ALERTS. THE PATIENT HAD A CARDIAC ARREST AND DIED.

  Patient problems: Cardiac Arrest; Death

  MAUDE report 9125090 ↗
• InjuryJun 11, 2019Delayed Alarm

  THE CUSTOMER REPORTED THAT ROOM 306 ALERTED A VTACH ON (B)(6) 2019 AT 9:47:03. THERE WAS A DELAY OF ALARMS VIA THE PAGING SYSTEM. NO INFORMATION WAS RECEIVED INDICATING THE DEVICE WAS NOT A CONTRIBUTING FACTOR IN THE EVENT. THE TYPE OF ADVERSE EVENT WAS NOT PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8686332 ↗
• DeathJan 24, 2018Defective Alarm

  THE CUSTOMER REPORTED THAT ON (B)(6) 2018, AS ALARMING STOPPED THROUGH THE PAGING (IEM) SYSTEM AT 10:17AM. THE PATIENT LEADS OFF OF TELEMETRY STARTING HAPPENING AT 17:30PM, AND NO IEM LEADS OFF ALERTS WERE RECEIVED. AT 19:00, THEY FOUND THE PATIENT IN ROOM 335 IN 3 SOUTH EXPIRED. THE PATIENT DIED.

  Patient problems: Death

  MAUDE report 7215509 ↗