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
Event or Problem Description
Original complaint (from (b)(4)): "the pt states she had a severe reaction to the patch, she removed and returned it to the prescribing hospital.The hospital prescribed her cortisone cream and pill.The pt states the rash stayed for months".Additional information: available information indicates the patient experienced irritation at the device application site.The patient sought medical treatment and was prescribed a topical corticosteroid cream and an oral steroid medication.The patient reported that the irritation was localized to the exact area where the monitor had been worn and did not spread beyond the application site.
Additional Manufacturer Narrative
The device was unavailable for evaluation despite multiple documented retrieval attempts and was ultimately unable to be returned for investigation.Review of the associated device history record (dhr (b)(4)) confirmed device traceability, including a build date of (b)(6)2025, expiration date of (b)(6)2027, and battrode lot number 045953.Review of the available manufacturing records did not identify any manufacturing nonconformances or anomalies that would indicate the device failed to meet established release requirements prior to distribution.The associated certificate(s) of conformance and manufacturing records were available for review through the identified dhr.Based on the available information, there is no evidence of a device malfunction, manufacturing nonconformance, or device failure that caused or contributed to the reported event.The cam product instructions for use (ifu) lists skin irritation, allergic skin reactions and allergic symptoms as potential risks associated with device use.The ifu instructs patients to remove the cam immediately and contact their physician if irritation such as redness, severe itching, or allergic symptoms develop.

• 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: 50487120
• Report Number: 3014226707-2026-00009
• Device Sequence Number: 10094049
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/27/2026

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 Model Number: B1400
• Device Lot Number: 194545
• 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: 07/30/2026
• Initial Report FDA Received Date: 08/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2025
• 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: 35 YR
• Patient Sex: Unknown