BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIAN SYSTEM

    MDR report key: 19051050 · Received April 4, 2024

    Report

    Report Number
    MW5153561
    Event Type
    Malfunction
    Date Received
    April 4, 2024
    Date of Event
    February 23, 2024
    Report Date
    April 2, 2024
    Manufacturer
    AVERTIX MEDICAL INC.
    Product Code
    QBI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    501
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE ISSUE OCCURRED (B)(6) 2024 WHEN THE PATIENT REPORTED TO HER DOCTOR WITH A SEE DOCTOR ALERT FROM THE DEVICE. AT THE DOCTOR'S OFFICE AN ATTEMPT WAS MADE TO INTERROGATE THE DEVICE; HOWEVER THE DEVICE WAS NOT ABLE TO COMMUNICATE WITH THE PROGRAMMER. THE PHYSICIAN WAS MADE AWARE OF THE ISSUE AND THE PHYSICIAN SPOKE TO THE PATIENT AT THAT TIME AND INDICATED THAT THE DEVICE SHOULD BE EXPLANTED IN ORDER TO PERFORM AN INVESTIGATION TO DETERMINE THE ROOT CAUSE OF THE FAILURE. THE PATIENT DECIDED TO HAVE THE DEVICE EXPLANTED AND REPLACED AND THAT PROCEDURE WAS PERFORMED ON (B)(6) 2024. THE DEVICE WAS RECEIVED AT THE DECONTAMINATION CENTER ON (B)(6) 2024. IT WAS DECONTAMINATED AND RETURNED TO AVERTIX FOR INVESTIGATION IN APRIL, 2024. THE FOLLOWING ISSUE WAS CREATED IN THE QMS OF AVERTIX FOR THIS PROBLEM: ISSUE 94 ISSUE 48 WAS ESCALATED TO A COMPLAINT FOR INVESTIGATION: COMPLAINT 65 COMPLAINT 65 WAS ASSIGNED TO AN EXISTING CAPA FOR CORRECTIVE AND PREVENTIVE ACTION DETERMINATIONS: CAPA 12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143973 GUARDIAN SYSTEM ACUTE CORONARY SYNDROME EVENT DETECTOR QBI AVERTIX MEDICAL INC. AMSG3-E 121720V0209530000037

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male