MAUDE Adverse Event Report: CARDIAC INSIGHT, INC. CARDEA SOLO; CARDEA SOLO SENSOR M300

Model Number	M300
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Erythema (1840); Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545)
Date of Event	07/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Interviewing/communicating with the healthcare professional on how the m300 (sensor) was applied and their knowledge and the patient's condition and progress was part of the investigation.Addiitonally manufacturing records and materials were reviewed and no discrepancies were identified.Follow-up with the clinic (cypress heart & vascular care, cypress, tx) indicated that the patient did well with topical steroid cream.
Event or Problem Description
Patient experienced severe rash and blistering of her skin during wear of the m300 (sensor).The patient started experiencing some itching, burning and discomfort after wearing the patch for 1-2 days.Due to discomfort, the patient removed the sensor after wearing it for 4 days and 21 hours (b)(6) 2023).Staff said she came to the clinic holding a wet compress on the wound and requested to speak with the medical staff.She described that she had some discomfort and removed the sensor early due to concerns, when she removed the patch that's when her skin showed the blistering and the rash.Physician initially suggested at-home remedies and care.However, after a week, the area wasn't healling so he provided the patient with a topical steroid cream and is monitoring her healing process.It was reported (b)(6) 2023 the patient did well with the topical steroid cream.Although temperatures were above normal during the wear period, patient reported to have spent most of the wear period time indoors and was not working in the sun or doing many outdoor activities.
Event or Problem Description
Patient experienced severe rash and blistering of her skin during wear of the m300 (sensor).The patient started experiencing some itching, burning and discomfort after wearing the patch for 1-2 days.Due to discomfort, the patient removed the sensor after wearing it for 4 days and 21 hours ((b)(6) 2023).Staff said she came to the clinic holding a wet compress on the wound and requested to speak with the medical staff.She described that she had some discomfort and removed the sensor early due to concerns, when she removed the patch that's when her skin showed the blistering and the rash.Physician initially suggested at-home remedies and care.However, after a week, the area wasn't healing so he provided the patient with a topical steroid cream and is monitoring her healing process.It was reported (b)(6) 2023 the patient did well with the topical steroid cream.Although temperatures were above normal during the wear period, patient reported to have spent most of the wear period time indoors and was not working in the sun or doing many outdoor activities.
Additional Manufacturer Narrative
D4 has udi related data quality updates.Upon review, the following corrections were made to d9 (device returned), h3 (device evaluated), and h6 (investigation finding).B4 (date of this report), g6 (type of report) and h2 (if follow-up, what type) were updated accordingly.

• Brand Name: CARDEA SOLO
• Common Device Name: CARDEA SOLO SENSOR M300
• Manufacturer (Section D): CARDIAC INSIGHT, INC.; 2375 130th avenue ne; suite 101; bellevue WA 98005
• Manufacturer (Section G): CARDIAC INSIGHT, INC.; 2375 130th ave ne; suite 101; bellevue WA 98005
• Manufacturer Contact: adena riemer ; 2375 130th avenue ne, suite 101; bellevue, WA 98005 ; 2065962071
• MDR Report Key: 18332737
• Report Number: 3010342616-2023-00001
• Device Sequence Number: 12440563
• Product Code: DSH
• UDI-Device Identifier: 00857553006115
• UDI-Public: (01)00857553006115(17)240523(10)DC403
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/02/2024
• Device Model Number: M300
• Device Catalogue Number: M300
• Device Lot Number: DC403
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Female