eCareManager 4.7Recalls & reported problems
Visicu, Inc. · Telehealth Center Product License · Class 2
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838115460), received between Aug 28, 2024 and Aug 28, 2024 — classified as 1 death.
The most frequently reported specific device problem is “Intermittent Communication Failure” (1 report).
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
Most reported problems
Device problems
- Intermittent Communication Failure1
Patient problems
- Cardiac Arrest1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathAug 28, 2024Intermittent Communication Failure; Intermittent Communication Failure
THE CUSTOMER REPORTING A DELAY IN PROVIDING TREATMENT TO A PATIENT IN THE SICU IN CARDIAC ARREST, REPORTEDLY ASSOCIATED WITH AN ISSUE WHERE THE CAREGILITY EQUIPMENT WAS NOT ALLOWING MORE THAN ONE PERSON ON A CAMERA AT A TIME. THE BEDSIDE RN¿S WERE UNENGAGED AND APPARENTLY UNTRAINED IN CPR AND THE PATIENT WAS IN CARDIAC ARREST FOR AT LEAST 90 SECONDS. THE RN WAS ON CAMERA AND IMPLORING THE BEDSIDE TO GET HELP AND BEGIN CPR. THE PHYSICIAN WAS AWARE, BUT GIVEN THE LIMITATIONS OF CAREGILITY, UNABLE TO OPERATE THE CAMERA TO BEGIN CARE. IN THE MIDST OF THIS, ASSISTANT NURSE MANAGER HAD TO CALL THE MICU DIRECTOR TO ASK FOR BEDSIDE ASSISTANCE, WHICH WAS PROVIDED. INITIAL GFE RESPONSE FROM THE CUSTOMER STATES THAT, THEY ARE UNCLEAR WHETHER ANY ALARMS GENERATED BUT ¿OFTEN THOUGH CARDIAC ARREST DOES NOT TRIGGER ALARMS.¿ THE CUSTOMER WAS UNAWARE OF THE PATIENT OUTCOME BUT STATED THAT THEY WERE CRITICALLY ILL, IN CARDIAC ARREST AND THEY FEEL THAT THE DELAY IN CARE WOULD BE A CONTRIBUTING FACTOR TO A NEGATIVE OUTCOME, IF SUCH AN OUTCOME DID OCCUR. OF NOTE, IN TERMS OF THE HOSPITAL WORKFLOW AND STAFFING RATIOS, GFE RESPONSE INDICATES THE ¿RN¿S WORK A 1:50 RATIO¿ AND FINDING/GATHERING THE APPROPRI
Patient problems: Cardiac Arrest
MAUDE report 20084654 ↗
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 4.5Visicu, Inc. · System, network and communication, physiological monitors1 recall1 death1 report
- eCareManager 4.3Visicu, Inc. · System, network and communication, physiological monitors1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.