BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLUMAT MC AGILIA

    MDR report key: 9717533 · Received February 17, 2020

    Report

    Report Number
    3000240707-2020-00015
    Event Type
    Malfunction
    Date Received
    February 17, 2020
    Date of Event
    January 20, 2020
    Report Date
    January 20, 2020
    Manufacturer
    FRESENIUS VIAL S.A.S.
    Product Code
    FRN
    PMA / PMN Number
    K121613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    DEFECTIVE POWER SUPPLY BOARD DEVICE HISTORY RECORD WAS REVIEWED, NO EVENT LINKED TO THE REPORTED ISSUE WAS OBSERVED. SEVERAL ERRORS 16-0100 / DISCONNECT BATTERY WERE FOUND DURING THE DEVICE LOG REVIEW AND CONFIRMS THE REPORTED EVENT. THE DEVICE WAS RECEIVED FOR INVESTIGATION. AS SOON AS THE DEVICE WAS SWITCHED ON, THE ERROR 16-0100 / BATTERY DISCONNECTEED APPEARED ON SCREEN. THE REPORTED EVENT IS REPRODUCED. FUNCTIONAL TEST FOUND THAT NO CURRENT FOR BATTERY CHARGE WAS DELIVERED BY THE POWER SUPPLY BOARD WHICH INDICATES THAT THE CAUSE OF THE ISSUE IS NOT LINKED TO BATTERY BUT TO A DEFECTIVE POWER BOARD. A REAR ASSEMBLY REPLACEMENT WAS DONE IN ORDER TO CONFIRM THIS FINDING. ONCE DONE THE DEVICE WORKED AS EXPECTED. IN ADDITION, A BATTERY LIFE TEST WAS PERFORMED (TEST 13), AFTER A FULL CHARGE, RESULTS WERE COMPLIANT WITH IFU SPECIFICATIONS. EXTERNAL VISUAL CHECK OF THE SUPPLY BOARD DOES NOT SHOW ANY VISIBLE DEFECT THEREFORE THE ROOT CAUSE REMAINS UNKOWN.

    Description of Event or Problem · 1

    DEFECTIVE POWER SUPPLY BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180188 VOLUMAT MC AGILIA INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1