BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM

    MDR report key: 12646227 · Received October 18, 2021

    Report

    Report Number
    2016493-2021-65143
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    September 27, 2021
    Report Date
    October 27, 2021
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-2909-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    OMIT : A070803 - FAILURE TO POWER UP (1476), G07001 - PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE, B21 - TYPE OF INVESTIGATION NOT YET DETERMINED, C21 - RESULTS PENDING COMPLETION OF INVESTIGATION AND D16 - CONCLUSION NOT YET AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WON'T TURN ON / OFF. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    PER 803.52(F)(11)(III) THE INFORMATION PROVIDED WAS OBTAINED FROM SERVICING ACTIVITIES PERFORMED ON THE DEVICE. THERE WERE NO ADDITIONAL DETAILS OBTAINABLE OR PROVIDED AT THE TIME OF SERVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WON'T TURN ON / OFF. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1544860 ALARIS SYSTEM PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1