BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOMEMS POWER SUPPLY

    MDR report key: 13581862 · Received February 22, 2022

    Report

    Report Number
    3004936110-2022-00077
    Event Type
    Malfunction
    Date Received
    February 22, 2022
    Date of Event
    November 18, 2021
    Report Date
    February 22, 2022
    Manufacturer
    ST. JUDE MEDICAL, INC. - CARDIOMEMS
    Product Code
    MOM
    PMA / PMN Number
    P100045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE PATIENT ELECTRONICS UNIT (PEU) MODEL # CM1100/ SERIAL # (B)(4) WITH ACCESSORIES WAS RECEIVED FOR EVALUATION. PHYSICAL DAMAGE WAS NOTED TO THE 12 VOLT DC SIDE OF THE POWER SUPPLY. THE RETURNED UNIT PASSED SOFTWARE EVALUATION. THE PEU WAS PLUGGED IN AND POWERED ON SUCCESSFULLY WITH A KNOWN GOOD TESTING UNIT. DIAGNOSTIC TESTING WAS PERFORMED AND CONFIRMED THE UNIT PASSED. THE REPORTED COMPLAINT WAS CONFIRMED; HOWEVER, THE CAUSE OF THE EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THE POWER CORD SPARKED. THE UNIT WAS REPLACED. DURING INVESTIGATION THE POWER SUPPLY CORD WAS NOTED TO BE FRAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820596 CARDIOMEMS POWER SUPPLY SYSTEM, HEMODYNAMIC, IMPLANTABLE MOM ST. JUDE MEDICAL, INC. - CARDIOMEMS CM1110

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female