BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 13315817 · Received January 21, 2022

    Report

    Report Number
    3012307300-2022-01390
    Event Type
    Malfunction
    Date Received
    January 21, 2022
    Report Date
    January 21, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FRN
    UDI-DI
    15019517150001
    PMA / PMN Number
    K111275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. VISUAL INSPECTION DID FOUND THE DEVICE INTACT. THE CUSTOMER STATED PROBLEM WAS CONFIRMED. THE DEVICE WAS STARTED AND ALARMED EC(B)(4) WHICH IS AN ISSUE WITH THE WATCHDOG CIRCUITRY. REPLACED CIRCUIT BOARD. THE ROOT CAUSE COULD NOT BE DETERMINED. A DHR REVIEW WAS PERFORMED SUBSEQUENT TO THE MANUFACTURING OF THE DEVICE AND PRIOR TO ITS RELEASE. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DHR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DEVICE DISPLAYED ERROR (B)(6) DURING TESTING. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610850 CADD PUMP, INFUSION FRN SMITHS MEDICAL ASD, INC. 2120 15019517150001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown