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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record (dhr) for unit (b)(6) corresponding to complaint reference number (b)(4) and mdr report key 24656439 was reviewed for compliance with the established device master record (dmr), including certificates of conformance for patient contact materials.No discrepancies or instances of nonconformance were identified that could have caused or contributed to the reported event.Records indicate that approximately 13 days and 3 hours of analysis time was obtained from the device, resulting in a successfully completed clinical report.The initial report described a dermatologic reaction at the device placement site, including rash, blistering, and spread, with an indication that prescription medical intervention was required.Additional information received on 7-may-2026 confirmed that the patient was treated with over-the-counter medications, specifically topical hydrocortisone and oral cetirizine (zyrtec), with no prescription medications administered.The cam product instructions for use (ifu) identifies skin irritation and allergic reactions as potential risks associated with device use and instructs patients to remove the device and contact a physician if irritation such as redness, severe itching, or allergic symptoms occur.
Event or Problem Description
Original complaint (from (b)(4): "parent of pt called to report that their child had a severe reaction to the adhesive of the monitor.They described it as an itchy red rash that had formed blisters that spread and required medical intervention" on (b)(6) 2026, a complaint was received reporting that a pediatric patient experienced a dermatologic reaction at the site of monitor adhesive application, described as an itchy red rash with blistering that spread to approximately three times the size of the device placement area.Medical evaluation was sought, and it was initially reported that prescription medication was provided to treat a potential infection; however, specific medication details could not be obtained prior to mdr submission on 20-mar-2026.Additional information received on 7-may-2026 confirmed the patient was treated with over-the-counter medications, specifically topical hydrocortisone and cetirizine (zyrtec), with no prescription medications administered.

• 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
• Manufacturer Contact: 220 120th avenue ne; suite 100; bellevue, WA 98005
• MDR Report Key: 25193530
• Report Number: 3014226707-2026-00003
• Device Sequence Number: 15974697
• 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): 03/20/2026

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: 190064
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Initial Report FDA Received Date: 05/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Age: 9 YR
• Patient Sex: Unknown