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	Anaphylactic Shock (1703); Hypersensitivity/Allergic reaction (1907)
Date of Event	12/05/2023
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), has been reviewed for compliance with established device master record (dmr), including certificates of conformance for patient contact materials.Examination determined no discrepancies or instances of non-conformity within the dhr that could have contributed to the reported event.Further discussion with the patient revealed a predisposition to a broad spectrum of allergens, including proclivity for anaphylactic reactions.The patient's acknowledgment of potential risks outlined in the cam® instructions for use, specifically regarding skin allergies, has been documented.The patient determined that the benefits of using the device to investigate their cardiac symptoms justify the potential for such reactions.The specific cause of the reported event cannot be determined.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 submitted complaint file: "patient started wearing the cam on 05-dec-2023 and called (b)(6) on 06-dec-2023 and complained of skin irritation and shortness of breath.She had to use her epi pen.She removed the cam.The provider does not want a new cam placed." note: further communication follow-up determined there was no skin irritation.All other information from the original complaint description was verified.

• 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: 18503909
• Report Number: 3014226707-2023-02092
• Device Sequence Number: 7863508
• Product Code: DSH
• UDI-Device Identifier: 40851398007014
• UDI-Public: 40851398007014
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2024

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
• Device Expiration Date: 11/22/2024
• Device Model Number: B1400
• Device Lot Number: 182454
• 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: 12/13/2023
• Initial Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2022
• 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: 33 YR
• Patient Sex: Unknown