BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD

    MDR report key: 14247258 · Received April 28, 2022

    Report

    Report Number
    3012307300-2022-07141
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Report Date
    October 25, 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

    OTHER, OTHER TEXT: H3: DEVICE EVALUATED BY MANUFACTURER: UPDATED. H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED. H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED TO MANUFACTURING FOR INVESTIGATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED. VISUAL INSPECTION CONFIRMED THAT THE DEVICE TAMPER SEAL WAS INTACT UPON RECEIPT. ERROR CODES WERE FOUND IN THE EHL (EVENT HISTORY LOG). THE CUSTOMER REPORTED PROBLEM WAS NOT DUPLICATED DURING THE INVESTIGATION. ROOT CAUSE OF THE REPORTED EVENT IS UNKNOWN, BUT FLUID INGRESSION WAS FOUND ON THE DOWNSTREAM SENSOR. IT IS RECOMMENDED THAT THE DOWNSTREAM SENSOR BE REPLACED. THE RETURNED PRODUCT IS BEYOND A YEAR FROM THE MANUFACTURE DATE AND THERE WAS NO INDICATION OF A MANUFACTURING DEFECT DURING THE INVESTIGATION, SO A DEVICE HISTORY RECORD DHR REVIEW IS NOT REQUIRED. SERVICE HISTORY REVIEW IDENTIFIED THIS DEVICE HAS NOT BEEN IN FOR SERVICE IN THE PREVIOUS YEAR AND THERE WAS NO INDICATION OF A SERVICE ISSUE DURING THE INVESTIGATION., CORRECTED DATA: D4: CORRECTION: MODEL NUMBER: 6400, D5: CORRECTION: OPERATOR OF DEVICE: UNKNOWN, E4: CORRECTION: INITIAL REPORTER SENT TO FDA: UNKNOWN

    Description of Event or Problem · 0

    ORACLE RO 1223184: DOUBLE BEEP WITH CASSETTE (DURING TESTING / NO PATIENT INJURY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119810 CADD PUMP, INFUSION FRN ST PAUL 6400 10610586019548

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown