BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOMEMS PATIENT ELECTRONIC SYSTEM

    MDR report key: 21985028 · Received May 8, 2025

    Report

    Report Number
    3004936110-2025-00981
    Event Type
    Malfunction
    Date Received
    May 8, 2025
    Date of Event
    March 17, 2025
    Report Date
    May 8, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    MOM
    UDI-DI
    05414734509800
    PMA / PMN Number
    P100045
    Removal / Correction Number
    FA-Q323-HF-4
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE CARDIOMEMS PATIENT ELECTRONIC SYSTEM WAS RECEIVED FOR EVALUATION. EXTERNAL AND INTERNAL VISUAL INSPECTIONS OF UNIT REVEALED THAT THE POWER SUPPLY CABLE AND POWER CORD CABLE ARE IN GOOD CONDITION, AND THE RIGHT-ANGLE EXTENSION CABLE WAS DEFECTIVE (RIGHT-ANGLE EXTENSION CABLE HAS EXPOSED WIRES), ALSO THE RETURNED 4G GSM MODEM WAS UNABLE TO PASS POTS MODEM DURING DIAGNOSTIC TESTING, THEREFORE, A GOLDEN 4G GSM MODEM AND A GOLDEN RIGHT-ANGLE EXTENSION CABLE WERE USED IN ALL FUTURE TESTING. NO SOFTWARE MALFUNCTIONS, ERRORS, WARNINGS, OR ANOMALIES WERE OBSERVED DURING UNIT BOOT OR DURING HANDHELD TOUCH SCREEN COMMANDS. PATIENT DATA BACKUP WAS PERFORMED SUCCESSFULLY USING RETURNED 4G GSM MODEM. IT WAS REPORTED THAT PES COULD NOT POWER ON DUE TO THE EXPOSED WIRES ON POWER CONNECTOR PLUG-CONFIRMED. ADDITIONAL ISSUE REVEALED THAT RETURNED 4G GSM MODEM WAS UNABLE TO PASS POTS MODEM DURING DIAGNOSTIC TEST-CONFIRMED.

    Description of Event or Problem · 0

    THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS CONFIRMING EXPOSED WIRES OF THE POWER EXTENSION CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946971 CARDIOMEMS PATIENT ELECTRONIC SYSTEM System, hemodynamic, implantable MOM ABBOTT MEDICAL CM1100 10161199 05414734509800

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Unknown