BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDFUSION

    MDR report key: 10363608 · Received August 4, 2020

    Report

    Report Number
    3012307300-2020-07791
    Event Type
    Malfunction
    Date Received
    August 4, 2020
    Report Date
    August 4, 2020
    Manufacturer
    ST PAUL
    Product Code
    FRN
    UDI-DI
    10610586043567
    PMA / PMN Number
    K111386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL SYRINGE INFUSION PUMPS/MEDFUSION 4000 PUMPS PHARMGUARD SERVER DATA WAS ACCESSED TO DETERMINE WHICH PUMPS EXPERIENCED PRIMARY AUDIBLE ALARMS (POST AND BGND) DURING 2019-20. THE PUMP EXPERIENCED A PRIMARY AUDIBLE ALARM BGND TEST. NO PATIENT ADVERSE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824805 MEDFUSION SYRINGE PUMP FRN ST PAUL 4000 10610586043567

    Patients

    Seq Age Sex Outcome Treatment
    1