BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOMEMS POWER SUPPLY

    MDR report key: 25026719 · Received April 29, 2026

    Report

    Report Number
    3004936110-2026-00819
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    March 6, 2026
    Report Date
    April 29, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MOM
    PMA / PMN Number
    P100045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE POWER SUPPLY AND ONE POWER CORD MODEL WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION VERIFIED THE POWER SUPPLY WAS FRAYED AND WIRES WERE EXPOSED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THAT NO NON-CONFORMANCE'S 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, CONFIRMING EXPOSED WIRES OF THE POWER SUPPLY. THE POWER ACCESSORIES WERE REPLACED AND THERE WERE NO ADVERSE CONSEQUENCES REPORTED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349202 CARDIOMEMS POWER SUPPLY System, hemodynamic, implantable MOM ABBOTT MEDICAL CM1110

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female