MAUDE Adverse Event Report: ANALOG DEVICES SENSINEL CARDIOPULMONARY MANAGEMENT SYSTEM

Model Number	ADCP1100-BETA
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
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.
Additional Manufacturer Narrative
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.The device in question was used as part of an investigational study, which the patient has completed and is no longer in use.There were no adverse events or no need for medical intervention related to this malfunction.The device has not yet been returned for evaluation to confirm the suspected hardware malfunction.However, the reported signal characteristics are consistent with a recent pattern of acoustic wire-break issues that analog is addressing through an active capa.

• Brand Name: SENSINEL CARDIOPULMONARY MANAGEMENT SYSTEM
• Common Device Name: CARDIOPULMONARY MANAGEMENT SYSTEM
• 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: 23313085
• Report Number: 3000130829-2025-00003
• Device Sequence Number: 20287341
• Product Code: MWI
• UDI-Device Identifier: 00860006382322
• UDI-Public: (01)00860006382322(17)250608
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 06/30/2025

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/08/2025
• Device Model Number: ADCP1100-BETA
• Device Catalogue Number: ADI11569
• Device Lot Number: 28146808
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Female