BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLCANO CORE MOBILE SYSTEM MEDICAL EQUIPMENT

    MDR report key: 17515645 · Received August 11, 2023

    Report

    Report Number
    3008363989-2023-00040
    Event Type
    Injury
    Date Received
    August 11, 2023
    Date of Event
    July 24, 2023
    Report Date
    August 11, 2023
    Manufacturer
    VOLCANO CORPORATION
    Product Code
    IYO
    PMA / PMN Number
    K173860
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURE¿S POLICY. BLOCKS H3 & H6: AT THE CUSTOMER SITE, A FIELD SERVICE ENGINEER CHECKED THE CORE MOBILE SYSTEM AND FOUND NO POWER ISSUE. REGARDLESS, THE POWER CORD AND STRAIN RELIEF WERE REPLACED. THE UNIT WAS TURNED ON AND RAN FOR APPROXIMATELY 2.5 HOURS WITH NO POWER ISSUES. THE SYSTEM MET THE SPECIFICATION FOR THE PERFORMED SERVICE AND WAS RETURNED FOR USE. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN EMERGENT CORONARY PCI OF LAD PROCEDURE, THE CORE MOBILE SYSTEM SHUT DOWN AND WOULD NOT TURN ON. SEVERAL ATTEMPTS WERE MADE TO TRY TO GET POWER TO THE SYSTEM, BUT WAS UNSUCCESSFUL. IVUS ATTEMPT WAS ABORTED, AND PATIENT WAS TREATED WITH ANGIO ONLY. THERE WAS NO REPORT OF PATIENT HARM. THIS ADVERSE EVENT AND PRODUCT PROBLEM IS BEING SUBMITTED DUE TO THE SYSTEM SHUT DOWN DURING AN EMERGENT PROCEDURE, RESULTING IN A DELAY OF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564643 VOLCANO CORE MOBILE SYSTEM MEDICAL EQUIPMENT SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC IYO VOLCANO CORPORATION 400-0100.01

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other