BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYSTEM PC UNIT

    MDR report key: 10591171 · Received September 26, 2020

    Report

    Report Number
    2016493-2020-13531
    Event Type
    Malfunction
    Date Received
    September 26, 2020
    Report Date
    September 3, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K091308
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED PROBLEM WAS CONFIRMED. THE DEVICE WAS REPAIRED, PASSED ALL REQUIRED TESTING AND SPECIFICATIONS, AND RELEASED BACK TO THE CUSTOMER. THERE ARE CAPA #¿S NOTED FOR THE FOLLOWING PARTS REPLACED THAT HAVE AN ALREADY EXISTING CAPA. CAPA # 1120033 A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(6) WAS PERFORMED FROM DATE OF MANUFACTURE 04/25/2020 TO THE PRESENT DATE 10/19/2020 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING. ALSO, THERE WERE NO PRODUCTION FAILURES INDICATED ON THE SOURCE DEVICE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, THE AFFECTED DEVICE HAVE NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055638 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1