BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOVIT AT-180

    MDR report key: 19861213 · Received July 30, 2024

    Report

    Report Number
    8030978-2024-62821
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Report Date
    July 25, 2024
    Manufacturer
    SCHILLER AG
    Product Code
    DPS
    PMA / PMN Number
    K183425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVICE INCORRECTLY DISPLAYED AN INTERPRETATION FOR A PACEMAKER, ALTHOUGH THE PATIENT WAS NOT WEARING A PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245156 CARDIOVIT AT-180 CARDIOVIT AT-180 DPS SCHILLER AG 0A.110000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other