eCareManager 4.5Recalls & reported problems
Visicu, Inc. · Telehealth Center Product License · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838102910), received between Nov 5, 2024 and Nov 5, 2024 — classified as 1 death.
The most frequently reported specific device problem is “Intermittent Communication Failure” (1 report).
1 FDA recall record name this device's identifier.
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.
Reports received per month
Recalls naming this device
- Jan 3, 2022Terminated
eCareManager (eCM) Sentry Score software not approved for use
Z-0549-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Intermittent Communication Failure1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathNov 5, 2024Intermittent Communication Failure; Intermittent Communication Failure
CUSTOMER REPORTED TO PHILIPS THAT, THE BEDSIDE NURSE PUSHED THE ELERT BUTTON, BUT NO ALERT WAS RECEIVED REMOTELY AND THE PATIENT SUBSEQUENTLY PASSED AWAY.
Patient problems: Insufficient Information
MAUDE report 20607982 ↗
Other System, network and communication, physiological monitors devices
- Xhibit Xhibit CentralSpacelabs Healthcare (Washington), Inc · System, network and communication, physiological monitors3 deaths218 reports
- Infinity M540 MS26372Draeger Medical Systems, Inc. · System,Network And Communication,Physiological Monitors2 recalls9 reports
- CareEventPhilips Medical Systems Hsg · System, network and communication, physiological monitors2 recalls4 deaths7 reports
- XTR 96280Spacelabs Healthcare (Washington), Inc · SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS2 recalls0 reports
- CNS-2101 Central MonitorNihon Kohden Corporation · System, Network And Communication, Physiological Monitors3 deaths76 reports
- BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · System, Network And Communication, Physiological Monitors1 recall2 deaths5 reports
- eCareManager 4.3Visicu, Inc. · System, network and communication, physiological monitors1 recall0 reports
- eCareManager 4.2Visicu, Inc. · System, network and communication, physiological monitors1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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