MAUDE Adverse Event Report: ANALOG DEVICES SENSINEL CARDIOPULMONARY MANAGEMENT SYSTEM; Monitor, physiological, patient (without arrhythmia detection or alarms)

Model Number	ADCP1100-BETA
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
During routine data monitoring on (b)(6) 2025, the team noticed an erratic pattern in some measurement signals.On (b)(6), analog notified the patient and the healthcare provider of the identified issue and advised the patient to discontinue using the device.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.In coordination with the clinical site, a return material authorization was issued, and the patient was given a replacement device on (b)(6) 2025, following established procedures.The device in question was used as part of an investigational study, and there were no adverse events or no need for medical intervention related to this malfunction.When the original unit was returned to analog on (b)(6) 2025, it underwent standard return processing.X-ray analysis confirmed a break in the wire in the acoustic signal path.This explained the shifting acoustic signal baseline and intermittent simultaneous jumps/falls caused by the wire making and breaking contact with patient movement.The root cause was confirmed to be a hardware failure due to a broken connection in the acoustic signal path.

• Brand Name: SENSINEL CARDIOPULMONARY MANAGEMENT SYSTEM
• Common Device Name: Monitor, physiological, patient (without arrhythmia detection or alarms)
• Manufacturer (Section D): ANALOG DEVICES; 1 analog way; wilmington MA 01887
• Manufacturer (Section G): NEXT PHASE MEDICAL DEVICES; 110 forbes blvd; mansfield MA 02048
• Manufacturer Contact: sam rajkumar ; 1 analog way; wilmington, MA 01887
• MDR Report Key: 23789738
• Report Number: 3000130829-2025-00010
• Device Sequence Number: 20261928
• Product Code: MWI
• UDI-Device Identifier: 00860006382322
• UDI-Public: (01)00860006382322(17)260514
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K243216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Notification,Replace,Inspection
• Type of Report: Initial
• Report Date (Section B): 12/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 05/14/2026
• Device Model Number: ADCP1100-BETA
• Device Lot Number: 28894826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Unknown