BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 10744943 · Received October 27, 2020

    Report

    Report Number
    2016493-2020-28142
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Report Date
    April 27, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K091308
    Removal / Correction Number
    Z-1359-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    SOFT FAULT - 13 1033 149 PROBLEM DESCRIPTION (B)(6)2018 09:32:36 (B)(6) CAD FILE 2018-015464-241258 PROBLEM DESCRIPTION (B)(6)2018 15:55:42 (B)(6) HE WILL CALL BACK AND SEND BACK FOR 90 REPAIR. THE UNIT WAS JUST RECEIVED FROM SERVICE CENTER. NO SERIAL NUMBER PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE TSC TROUBLESHOOTING PROCESS. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS NOT PERFORMED BECAUSE THE SERIAL NUMBER WAS NOT PROVIDED. A DHR (DEVICE HISTORY RECORD) REVIEW CANNOT BE COMPLETED AS THE SERIAL NUMBER WAS NOT OBTAINED UPON RECEIPT OF THE COMPLAINT. ADDITIONALLY, A HISTORICAL REVIEW OF COMPLAINTS IN TRACKWISE CANNOT BE CONDUCTED. CAPA REFERENCE: (B)(4). THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    (B)(4). HE WILL CALL BACK AND SEND BACK FOR 90 REPAIR. THE UNIT WAS JUST RECEIVED FROM SERVICE CENTER. NO SERIAL NUMBER PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208601 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015

    Patients

    Seq Age Sex Outcome Treatment
    1