MAUDE Adverse Event Report: BARDY DIAGNOSTICS, INC. CAM SYSTEM; HEART MONITORING DEVICE

Model Number	B1400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Skin Inflammation/ Irritation (4545); Contact Dermatitis (4546)
Date of Event	03/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record (dhr) for unit whsy5-6tbs1 corresponding to complaint reference number (b)(4), has been reviewed for compliance with established device master record (dmr).Examination determined no discrepancies or instances of non-conformity within the dhr nor on device labeling/packaging that could have contributed to the reported event.This report has been compiled in accordance with the mandatory reporting requirements set forth under 21 cfr part 803 for serious injuries.The submission of this report is not to be construed as an acknowledgement by bardy diagnostics of any defect or malfunction in the product described herein.
Event or Problem Description
As written from the complaint (b)(4) description: "the patient left a typed note inside the box that states "on thursday (b)(6), i did not have abnormal heart symptoms but i did noticeredness around the device.By friday, i still had no heart symptoms but the redness had become more severe.I was concerned because i had suffered from adhesive allergies in the past.In addition to the redness around the device, by saturday the area included rash type bumps, itching, burning, and clear liquid drainage.Since the condition worsened, i was sent by va emergency to community urgent care.The described my condition as "contact dermatitis".They redressed the area but by that time the device was too saturated to stay in place.New bandages were applied and i was prescribed hydroxyz hcl 25 mg.I removed the new bandage and the device for return on monday (b)(6) without experiencing abnormal heart or chest symptoms since the original application."" additional information: the device was recieved for investigation on 09 apr 2025.Failure analysis concluded no device nonconformaties.

• Brand Name: CAM SYSTEM
• Common Device Name: HEART MONITORING DEVICE
• Manufacturer (Section D): BARDY DIAGNOSTICS, INC.; 220 120th avenue ne; suite 100; bellevue WA 98005
• Manufacturer (Section G): QUALITEL CORPORATION; WA
• Manufacturer Contact: 220 120th avenue ne; suite 100; bellevue, WA 98004
• MDR Report Key: 21923224
• Report Number: 3014226707-2025-00003
• Device Sequence Number: 21014988
• Product Code: DSH
• UDI-Device Identifier: 40851398007014
• UDI-Public: 40851398007014
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K233110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2025

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: 01/23/2026
• Device Model Number: B1400
• Device Lot Number: 188442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2024
• 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: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Unknown