BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOMEMS PATIENT ELECTRONIC SYSTEM

    MDR report key: 21403887 · Received February 18, 2025

    Report

    Report Number
    3004936110-2025-00344
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 21, 2025
    Report Date
    February 18, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FA-Q323-HF-4 CARDIOMEMS PES RIGHT ANGLE POWER EXTENSION CABLE FAILURE NOTICE ISSUED BY ABBOTT ON 04 OCT 2023. ONE CARDIOMEMS PATIENT ELECTRONIC SYSTEM WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION OF RETURNED MATERIAL REVEALED FUNCTIONAL DAMAGE TO RIGHT ANGLE EXTENSION CABLE IN THE FORM OF A PORTION OF THE 16 AWG 2C TS WIRE COMPLETELY BROKEN OFF FROM THE PVC OVERMOLD. EXPOSED BROKEN INTERNAL WIRES WERE VISIBLE FROM THIS DAMAGED AREA OF THE RIGHT-ANGLE EXTENSION CABLE. THE BACKPLATE OF THE DEVICE WAS REMOVED AND A STANDARD POWER SUPPLY WAS CONNECTED TO THE UNIT. THE UNIT WAS POWERED ON WITH NO ISSUES OBSERVED. 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 CONFIRMING EXPOSED AND FRAYED WIRES OF THE POWER EXTENSION CABLE. THE PATIENT ELECTRONICS DEVICE WAS REPLACED AND THERE WERE NO ADVERSE CONSEQUENCES REPORTED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2642041 CARDIOMEMS PATIENT ELECTRONIC SYSTEM System, hemodynamic, implantable MOM ABBOTT MEDICAL CM1100 9211818 05414734509800

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Unknown