SENSINEL™ CPM WEARABLE ADCP1100-WB-001Recalls & reported problems
Analog Devices, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00860006382322), received between Oct 16, 2025 and Dec 12, 2025 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component5
- Insufficient Device Problem Information3
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
DURING ROUTINE DATA MONITORING ON (B)(6) 2025, THE TEAM NOTICED AN ERRATIC PATTERN IN SOME MEASUREMENT SIGNALS. ON (B)(6) 2025, THE TEAM CONFIRMED INACCURATE READINGS IN 9 OUT OF 40 DIASTOLIC HEART SOUND STRENGTH MEASUREMENTS (22.5%). TWO SIGNAL PATTERNS WERE OBSERVED: (1) A SHIFT IN THE ACOUSTIC SIGNAL AWAY FROM THE EXPECTED BASELINE AND (2) ABRUPT SIMULTANEOUS JUMPS/FALLS IN BOTH ACOUSTIC AND IMPEDANCE SIGNALS. THESE ANOMALIES DID NOT ALIGN WITH COMMON USER ERRORS OR POOR DEVICE CONTACT, SUGGESTING A POTENTIAL HARDWARE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23789738 ↗MalfunctionDec 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2025, ANALOG DEVICES' TRIAGING TEAM ESCALATED THE QUALITY OF THIS PATIENT'S MEASUREMENT DATA. AS PART OF THE COMPLAINT INVESTIGATION, THE TEAM THEN NOTICED AN ERRATIC PATTERN IN SOME MEASUREMENT SIGNALS. ON (B)(6) 2025, THE TEAM CONFIRMED INACCURATE READINGS IN 4 OUT OF 35 DIASTOLIC HEART SOUND STRENGTH MEASUREMENTS (11.43%). TWO SIGNAL PATTERNS WERE OBSERVED: (1) A SHIFT IN THE ACOUSTIC SIGNAL AWAY FROM THE EXPECTED BASELINE AND (2) ABRUPT SIMULTANEOUS JUMPS/FALLS IN BOTH ACOUSTIC AND IMPEDANCE SIGNALS. THESE ANOMALIES DID NOT ALIGN WITH COMMON USER ERRORS OR POOR DEVICE CONTACT, SUGGESTING A POTENTIAL HARDWARE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23789675 ↗MalfunctionOct 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
DURING ROUTINE DATA MONITORING ON (B)(6) 2025, THE TEAM NOTICED AN ERRATIC PATTERN IN SOME MEASUREMENT SIGNALS. ON (B)(6) 2025, THE TEAM CONFIRMED INACCURATE READINGS IN 4 OUT OF 33 DIASTOLIC HEART SOUND STRENGTH MEASUREMENTS (12.12%). TWO ABNORMAL SIGNAL PATTERNS WERE OBSERVED: (1) A SHIFT IN THE ACOUSTIC SIGNAL AWAY FROM THE EXPECTED BASELINE AND (2) ABRUPT SIMULTANEOUS JUMPS/FALLS IN BOTH ACOUSTIC AND IMPEDANCE SIGNALS. THESE ANOMALIES DID NOT ALIGN WITH COMMON USER ERRORS OR POOR DEVICE CONTACT, SUGGESTING A POTENTIAL HARDWARE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23314406 ↗MalfunctionOct 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
DURING ROUTINE DATA MONITORING ON (B)(6) 2025, THE TEAM NOTICED AN ERRATIC PATTERN IN SOME MEASUREMENT SIGNALS. ON (B)(6) 2025, A RETROSPECTIVE REVIEW OF THE PATIENT DATA FOUND INACCURATE READINGS IN 5 OF 24 DIASTOLIC HEART SOUND STRENGTH MEASUREMENTS (20.83%). TWO ABNORMAL SIGNAL PATTERNS WERE OBSERVED: (1) A SHIFT IN THE ACOUSTIC SIGNAL AWAY FROM ITS EXPECTED BASELINE AND (2) ABRUPT SIMULTANEOUS JUMPS/FALLS IN BOTH ACOUSTIC AND IMPEDANCE SIGNALS. THESE ANOMALIES DID NOT ALIGN WITH COMMON USER ERRORS OR POOR DEVICE CONTACT, SUGGESTING A POTENTIAL HARDWARE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23314394 ↗MalfunctionOct 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
DURING ROUTINE DATA MONITORING ON (B)(6) 2025, THE TEAM NOTICED AN ERRATIC PATTERN IN SOME MEASUREMENT SIGNALS. ON (B)(6) 2025, THE TEAM CONFIRMED INACCURATE READINGS IN 4 OUT OF 18 DIASTOLIC HEART SOUND STRENGTH MEASUREMENTS (22.22%). TWO ABNORMAL SIGNAL PATTERNS WERE OBSERVED: (1) A SHIFT IN THE ACOUSTIC SIGNAL AWAY FROM THE EXPECTED BASELINE AND (2) ABRUPT SIMULTANEOUS JUMPS/FALLS IN BOTH ACOUSTIC AND IMPEDANCE SIGNALS. THESE ANOMALIES DID NOT ALIGN WITH COMMON USER ERRORS OR POOR DEVICE CONTACT, SUGGESTING A POTENTIAL HARDWARE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23314373 ↗MalfunctionOct 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
DURING ROUTINE MONITORING ON (B)(6) 2025, THE TEAM IDENTIFIED ERRATIC MEASUREMENT SIGNALS. ANALOG NOTIFIED THE PATIENT AND HEALTHCARE PROVIDER OF THE IDENTIFIED ISSUE AND ADVISED THE PATIENT TO DISCONTINUE USING THE DEVICE. ON (B)(6) 2025, A RETROSPECTIVE REVIEW OF THE PATIENT DATA FOUND INACCURATE READINGS IN 11 OF 42 RELATIVE TIDAL VOLUME MEASUREMENTS (26.19%) AND 41 OF 42 DIASTOLIC HEART SOUND STRENGTH MEASUREMENTS (97.62%). TWO ABNORMAL PATTERNS WERE NOTED: (1) A SHIFT OF THE ACOUSTIC SIGNAL FROM ITS EXPECTED BASELINE AND (2) ABRUPT, SIMULTANEOUS JUMPS OR DROPS IN BOTH ACOUSTIC AND IMPEDANCE SIGNALS. THESE FINDINGS WERE INCONSISTENT WITH COMMON USER ERRORS OR POOR DEVICE CONTACT, INDICATING A POTENTIAL HARDWARE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23313085 ↗MalfunctionOct 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
DURING ROUTINE DATA MONITORING ON (B)(6) 2025, THE TEAM NOTICED AN ERRATIC PATTERN IN SOME MEASUREMENT SIGNALS. ON (B)(6) 2025, THE TEAM CONFIRMED INACCURATE READINGS IN 26 OUT OF 35 DIASTOLIC HEART SOUND STRENGTH MEASUREMENTS (74.29%). TWO ABNORMAL SIGNAL PATTERNS WERE OBSERVED: (1) A SHIFT IN THE ACOUSTIC SIGNAL AWAY FROM THE EXPECTED BASELINE AND (2) ABRUPT SIMULTANEOUS JUMPS/FALLS IN BOTH ACOUSTIC AND IMPEDANCE SIGNALS. THESE ANOMALIES DID NOT ALIGN WITH COMMON USER ERRORS OR POOR DEVICE CONTACT, SUGGESTING A POTENTIAL HARDWARE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23312881 ↗MalfunctionOct 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
DURING ROUTINE DATA MONITORING ON (B)(6) 2025, THE TEAM NOTICED AN ERRATIC PATTERN IN SOME MEASUREMENT SIGNALS. THE TEAM CONFIRMED INACCURATE READINGS IN 1 OF 18 RELATIVE TIDAL VOLUME MEASUREMENTS (5.56%) AND 4 OF 9 DIASTOLIC HEART SOUND STRENGTH MEASUREMENTS (44.44%). TWO ABNORMAL SIGNAL PATTERNS WERE OBSERVED: (1) A SHIFT IN THE ACOUSTIC SIGNAL AWAY FROM ITS EXPECTED BASELINE AND (2) ABRUPT SIMULTANEOUS JUMPS/FALLS IN BOTH ACOUSTIC AND IMPEDANCE SIGNALS. THESE ANOMALIES DID NOT ALIGN WITH COMMON USER ERRORS OR POOR DEVICE CONTACT, SUGGESTING A POTENTIAL HARDWARE MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23312798 ↗
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