BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PC UNIT

    MDR report key: 10432854 · Received August 20, 2020

    Report

    Report Number
    2016493-2020-03016
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Date of Event
    August 4, 2020
    Report Date
    August 4, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K091308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED G4, H6(METHOD, RESULTS, CONCLUSION), H10. ADDITIONAL INFORMATION D10. A REVIEW OF THE DEVICE HISTORY RECORD FOR SN(B)(6) WAS PERFORMED FROM (B)(6)2019 TO (B)(6)2020 AND CONFIRMED THAT THIS DEVICE WAS 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 KEYPAD ISSUE- WON¿T TURN ON, SHOWS PWR.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED KEYPAD ISSUE- WON¿T TURN ON, SHOWS PWR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897579 ALARIS PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1