BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAM SYSTEM

    MDR report key: 23475994 · Received November 5, 2025

    Report

    Report Number
    23475994
    Event Type
    Malfunction
    Date Received
    November 5, 2025
    Date of Event
    September 9, 2025
    Report Date
    October 15, 2025
    Manufacturer
    BARDY DIAGNOSTICS INC
    Product Code
    DSH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PT HAD 7 DAY HOLTER DEVICE ON DISCHARGE FROM HOSPITAL 3 WEEKS LATER PT DROPPED OFF DEVICE AND CLAIMS SHE WAS MAKING REPORT WITH FDA FOR 3RD DEGREE BURNS ON HER CHEST. NO PICTURES ACCOMPANIED THE DEVICE. DEVICE APPEARS INTACT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2677786 CAM SYSTEM RECORDER, MAGNETIC TAPE, MEDICAL DSH BARDY DIAGNOSTICS INC R1000

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Other