SENSINEL™ CARDIOPULMONARY MANAGEMENT (CPM) SYSTEM) ADCP1100-PL-001Recalls & reported problems
Analog Devices, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00860006382315), received between Aug 11, 2025 and Aug 11, 2025 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Easy Bruising1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT PRESENTED TO THE HOSPITAL FOR ENROLLMENT IN THE SENSINEL PROGRAM. A REGISTERED NURSE (RN) EXPLAINED HOW THE DEVICE WORKS, INCLUDING SAFETY PRECAUTIONS AND POTENTIAL RISKS. DURING THE DISCUSSION, THE PATIENT DISCLOSED A HISTORY OF SENSITIVE SKIN, EASY BRUISING, AND CURRENT USE OF BLOOD THINNERS AND STEROIDS. THE RN EMPHASIZED THAT PARTICIPATION WAS VOLUNTARY AND THAT THE PATIENT COULD DECLINE OR STOP USING THE DEVICE AT ANY TIME. THE PATIENT WAS ALSO INSTRUCTED TO DISCONTINUE USE AND CONTACT THE CLINIC IF ANY BRUISING OR SKIN IRRITATION OCCURRED. THE PATIENT CHOSE TO PROCEED WITH ENROLLMENT. THE SENSINEL CPM SYSTEM WAS APPLIED TO THE CHEST, AND A BASELINE MEASUREMENT WAS SUCCESSFULLY COMPLETED. UPON DEVICE REMOVAL, THE RN OBSERVED BRUISING AT THE CONTACT SITE WITH THE WEARABLE HOUSING (NOT AT THE ELECTRODES). GIVEN THE OBSERVED BRUISING, THE PROVIDER DETERMINED THE PATIENT WAS NOT AN APPROPRIATE CANDIDATE FOR CONTINUED USE OF THE SENSINEL CPM SYSTEM. THE PATIENT WAS NOT SENT HOME WITH THE DEVICE. SHE REPORTED NO PAIN OR DISCOMFORT AT THE BRUISE SITE, EXPRESSED UNDERSTANDING OF THE DECISION, AND LEFT THE CLINIC IN GOOD SPIRITS. THE RN NOTIFIED ADI AND FOLLOWED UP WITH THE
Patient problems: Easy Bruising
MAUDE report 22777645 ↗
Other Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) devices
- Rad-97 9738Masimo Corporation · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1 death222 reports
- Xper Flex Cardio Physiomonitoring System Xper Flex Cardio FC2010 REV CPhilips Ds North America LLC · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls1 death42 reports
- Xper Flex Cardio Physiomonitoring System FC 2010Philips Ds North America LLC · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls2 deaths38 reports
- Welch Allyn, Inc. 901058Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls5 reports
- Welch Allyn, Inc. 901060Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls3 reports
- Welch Allyn, Inc. 901060Welch Allyn, Inc. · MONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)2 recalls2 reports
- McKesson Cardiology Hemo 14.0Change Healthcare Canada Company · Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)2 recalls2 deaths2 reports
- Change Healthcare Cardiology Hemo 14.2Change Healthcare Canada Company · Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)2 recalls1 death1 report
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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page