BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14069272 · Received April 10, 2022

    Report

    Report Number
    3012307300-2022-06137
    Event Type
    Malfunction
    Date Received
    April 10, 2022
    Report Date
    October 12, 2022
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586019548
    PMA / PMN Number
    K982838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A VISUAL INSPECTION AND FUNCTIONAL TEST WERE PERFORMED. VISUAL INSPECTION FOUND THE DEVICE IN GOOD CONDITION. ERROR WAS FOUND IN THE DEVICE EHL (EVENT HISTORY LOG) MULTIPLE TIMES. THE CUSTOMER STATED PROBLEM WAS NOT DUPLICATED. FOUND FLUID INGRESSION ON THE DOWNSTREAM OCCLUSION SENSOR CAUSE DOUBLE BEEP. DOWNSTREAM OCCLUSION SENSOR WAS REPLACED. THE CAUSE OF THE REPORTED PROBLEM COULD NOT BE DETERMINED. A DHR (DEVICE HISTORY REVIEW) WAS NOT CONDUCTED, BASED UPON REVIEW OF THE INFORMATION PROVIDED BY THE CUSTOMER, AS IT DOES NOT INDICATE A PROBLEM WITH THE INITIAL MANUFACTURE OR PRIOR REPAIR OF THE DEVICE. MODEL NUMBER: 6400.

    Description of Event or Problem · 0

    ORACLE RO 1220664: DOUBLE BEEP WITH CASSETTE (DURING TESTING / NO PATIENT INJURY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188388 CADD PUMP, INFUSION FRN ST PAUL 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown