BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM PC UNIT

    MDR report key: 11189915 · Received January 18, 2021

    Report

    Report Number
    2016493-2021-12319
    Event Type
    Malfunction
    Date Received
    January 18, 2021
    Report Date
    November 25, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD FOR SN 15421645 WAS PERFORMED FROM DATE OF MANUFACTURE 12/07/2018 TO THE PRESENT DATE 01/15/2021 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING. ALSO, THERE WERE NO PRODUCTION FAILURES INDICATED ON THE SOURCE DEVICE. THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. THE DEVICE WAS REPAIRED, PASSED ALL REQUIRED TESTING AND SPECIFICATIONS, AND RELEASED BACK TO THE CUSTOMER.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE DEVISE DOES NOT RECOGNIZE WHEN PLUGGED IN. NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(4) WAS PERFORMED FROM DATE OF MANUFACTURE 12/07/2018 TO THE PRESENT DATE 01/15/2021 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING. ALSO, THERE WERE NO PRODUCTION FAILURES INDICATED ON THE SOURCE DEVICE. THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. THE DEVICE WAS REPAIRED, PASSED ALL REQUIRED TESTING AND SPECIFICATIONS, AND RELEASED BACK TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVISE DOES NOT RECOGNIZE WHEN PLUGGED IN. NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82815 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown