BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM

    MDR report key: 23817692 · Received December 16, 2025

    Report

    Report Number
    3004936110-2025-06597
    Event Type
    Malfunction
    Date Received
    December 16, 2025
    Date of Event
    October 7, 2025
    Report Date
    December 16, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MOM
    UDI-DI
    05415067029331
    PMA / PMN Number
    P100045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF RETURNED MATERIAL REVEALED FUNCTIONAL DAMAGE TO THE GLOBAL SYSTEM FOR MOBILE COMMUNICATIONS (GSM) ANTENNA RESULTING IN EXPOSED CIRCUITRY/WIRES. DAMAGE TO THE GSM ANTENNA CAME IN THE FORM OF THE SUBMINIATURE VERSION A (SMA) CONNECTOR PORTION BROKEN OFF FROM THE REST OF THE COMPONENT. ONLY THE BROKEN OFF SMA CONNECTOR PORTION OF THE GSM ANTENNA WAS RETURNED. FUNCTIONAL DAMAGE WAS ALSO FOUND ON THE EXTERNAL PRINTER SERIAL CABLE ASSEMBLY IN THE FORM OF THE CONNECTOR D-SUB HOUSING RECEPTACLE BROKEN OFF FROM THE REST OF THE COMPONENT, RESULTING IN EXPOSED CIRCUITRY/WIRES. ONLY THE BROKEN OFF CONNECTOR D-SUB HOUSING RECEPTACLE OF THE PRINTER SERIAL CABLE WAS RETURNED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THAT NO NON-CONFORMANCES WERE IDENTIFIED THAT ARE RELATED TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS, IN WHICH THE GLOBAL SYSTEM FOR MOBILE COMMUNICATIONS (GSM) ANTENNA AND PRINTER SERIAL CABLE ASSEMBLY WERE FOUND TO BE BROKEN WITH EXPOSED CIRCUITRY/WIRES. THE HOSPITAL SYSTEM WAS REPLACED AND THERE WERE NO ADVERSE CONSEQUENCES REPORTED, AND NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2444704 CARDIOMEMS HOSPITAL ELECTRONICS SYSTEM System, hemodynamic, implantable MOM ABBOTT MEDICAL CM3000 7148153 05415067029331

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown