BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PC UNIT

    MDR report key: 10466489 · Received August 28, 2020

    Report

    Report Number
    2016493-2020-03465
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Report Date
    August 7, 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

    CORRECTED G4, H6(METHODS, RESULTS, CONCLUSION), H10 ADDED D10 A REVIEW OF THE DEVICE HISTORY RECORD FOR SN (B)(4) WAS PERFORMED FROM DATE OF MANUFACTURE 10/27/2017 TO THE PRESENT DATE 10/15/2020 AND CONFIRMED THAT THIS DEVICE WAS NOT PREVIOUSLY RETURNED FOR SERVICING AND THERE WERE NO PRODUCTION FAILURES WHICH CORRELATE TO THE CUSTOMER REPORTED ISSUE. THE CUSTOMER REPORTED ISSUE WAS CONFIRMED. THE DEVICE WAS REPAIRED, PASSED ALL REQUIRE 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. 1120033 FOR KEYPAD.

    Description of Event or Problem · 0

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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933632 ALARIS PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1