BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOMEMS PATIENT ELECTRONIC SYSTEM

    MDR report key: 18072707 · Received November 6, 2023

    Report

    Report Number
    3004936110-2023-01630
    Event Type
    Malfunction
    Date Received
    November 6, 2023
    Date of Event
    October 12, 2023
    Report Date
    November 6, 2023
    Manufacturer
    ST. JUDE MEDICAL, INC.
    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
    OH, 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 (B)(6) 2023. ONE CARDIOMEMS PATIENT ELECTRONIC SYSTEM WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION VERIFIED THE POWER EXTENSION CABLE WAS FRAYED AND WIRES WERE EXPOSED IN THE FORM OF THE DC JACK CONNECTOR COMPLETELY BROKEN OFF FROM THE PVC OVERMOLD. THE POWER CORD RETURNED WAS OBSERVED TO NOT BE THE CORRECT AC POWER CORD WITH FERRITE ¿ US/CANADA (600021007) LISTED IN THE FINISHED GOOD RECORD BUT INSTEAD WAS DETERMINED TO BE AN 8 FT MIN US CLASS II POWER CORD (CC-002367). THE CONNECTION BETWEEN IEC 60320 C7 CONNECTOR OF POWER CORD (CC-002367) AND RECEPTACLE OF POWER SUPPLY (CC-002403) WAS FOUND TO BE NOTICEABLY LOOSE. 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

    THE PATIENT REPORTED 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
    1917033 CARDIOMEMS PATIENT ELECTRONIC SYSTEM System, hemodynamic, implantable MOM ST. JUDE MEDICAL, INC. CM1100 7667498 05414734509800

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown