BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAM SYSTEM

    MDR report key: 20768807 · Received November 24, 2024

    Report

    Report Number
    3014226707-2024-02334
    Event Type
    Injury
    Date Received
    November 24, 2024
    Report Date
    November 24, 2024
    Manufacturer
    BARDY DIAGNOSTICS, INC.
    Product Code
    DSH
    UDI-DI
    40851398007014
    PMA / PMN Number
    K233110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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). 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.

    Description of Event or Problem · 0

    AN ECG REPORT WAS ASSOCIATED TO THE INCORRECT PATIENT AS A RESULT OF A REGISTRATION USER ERROR. THAT PATIENT WAS SUBSEQUENTLY PRESCRIBED ELIQUIS FOR AN ARRHYTHMIA THAT THEY DID NOT HAVE. THE HEALTHCARE PROVIDER INDICATED THE PATIENT DID NOT HAVE BLEEDING COMPLICATIONS FROM THE PRESCRIBED ELIQUIS. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. PATIENT AGE IS UNKNOWN. DATE OF EVENT IS UNKNOWN, BUT DID OCCUR WITHIN 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1707279 CAM SYSTEM HEART MONITORING DEVICE DSH BARDY DIAGNOSTICS, INC. B1400 184186 40851398007014

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other