eCareManager 4.1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838059832), received between May 15, 2018 and May 15, 2018 — classified as 1 death.

2 other recalls cover devices cleared under the same FDA submission (K012171, K171322); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathMay 15, 2018Adverse Event Without Identified Device or Use Problem

  THE PRELIMINARY INVESTIGATION INTO THE EVENTS OF (B)(6) 2018, BY PHILIPS, REVEALED THE FOLLOWING INFORMATION. AT 1:42 AM ¿ VITAL SIGNS MESSAGE DATA STOPPED FOR THE PATIENT. AT 1:45 AM ¿ BP VALUES RECEIVED FOR THE FINAL TIME. AT 1:51 AM ¿ VITALS STOPPED NOTIFICATION WAS SENT TO ALL RUNNING WORKSTATIONS. THIS NOTIFICATION WAS NOT DISMISSED AND REMAINED ON SCREEN FOR AN HOUR BEFORE BEING AUTO-DISMISSED BY THE SYSTEM. AT 3:27 AM ¿ HEART RATE DATA RECEIVED. AT 3:47 AM ¿ PATIENT WAS DISCHARGED FROM THE EICU SYSTEM DUE TO THEIR PASSING. DURING THE TIME BETWEEN MEASUREMENT, MESSAGES WERE RECEIVED BUT CONTAINED NO VALUES TO POST. THIS PATIENT WAS A LOW ACUITY PATIENT AND WAS ON AN INFREQUENT ROUNDING SCHEDULE BY THE EICU STAFF. WHEN THE EICU NURSE DID ROUND ON THE PATIENT, USING THE IN ROOM AUDIO/VISUAL EQUIPMENT, THE NURSE NOTICED THAT THE PATIENT WAS UNRESPONSIVE AND THAT PATIENT MONITORING LEADS WERE OFF THE PATIENT AND COULD BE SEEN LYING ON THE BED. THE NURSE THEN CONTACTED THE BEDSIDE STAFF AND RELAYED THEIR FINDINGS. PHILIPS PRELIMINARY INVESTIGATION CONCLUDES THAT THE EICU SYSTEM PERFORMED AS DESIGNED. THIS DEVICE IS NOT USED IN THE TREATMENT OR DIAGNOSIS OF PATIENTS, ACCORDING TO T

  Patient problems: Death

  MAUDE report 7513903 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012171, K171322. One submission often covers many models, so check the product and lot details in each record.

• Z-0399-2016 · Mar 27, 2015 · Terminated
  The eCareManager system. Software intended for use in data collection, storage and clinical information management with independent bedside devices, and ancillary systems that are
• Z-1474-2012 · Feb 22, 2012 · Terminated
  Philips eCareManager System, Model 865325, software versions 3.7, 3.7.1 and 3.8. Product Usage: The Philips eCareManager System software is intended for use in data collection,