BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIA VP MC WIFI CA

    MDR report key: 11735331 · Received April 27, 2021

    Report

    Report Number
    3000240707-2021-00049
    Event Type
    Malfunction
    Date Received
    April 27, 2021
    Date of Event
    March 31, 2021
    Report Date
    October 29, 2021
    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

    Narratives

    Description of Event or Problem · 0

    DEVICE HISTORY RECORD WAS REVIEWED, NO EVENT LINKED TO THE REPORTED ISSUE WAS OBSERVED. DUE TO DEVICE FAILURE THE LOG COULD NOT BE EXTRACTED THEREFORE ITS REVIEW COULD NOT BE PERFORMED. THE DEVICE WAS RECEIVED AT INFUSYSTEM AND ITS REPAIR WAS PERFORMED BY THEIR TECHNICAL TEAM. THE DEVICE WAS CONSTANTLY ALARMING WITH THE TRIGGERING OF TECHNICAL ERROR 98-004 WHICH CONFIRMS THE REPORTED EVENT. AS PER TECHNICAL MANUAL THE CPU BOARD WAS REPLACED AND SENT TO BRÉZINS FOR FURTHER INVESTIGATION. UPON VISUAL CHECK A DAMAGE ON THE U7 MEMORY CHIP WAS OBSERVED. IN ORDER TO GET A CLOSER LOOK AT THE DAMAGE, A HIGH DEFINITION CAMERA WAS USED AND IT REVEALED THAT THE MEMORY CHIP WAS CRACKED IN SEVERAL DIRECTIONS. NEVERTHELESS, THE PART WAS CROSS-TESTED TO PERFORM FUNCTIONAL TESTS HOWEVER ONCE THE DEVICE WAS SWITCHED ON THE TECHNICAL ERROR 98 WAS IMMEDIATELY TRIGGERED. THE REPORTED EVENT WAS REPRODUCED AND WAS DUE TO A DAMAGED CPU BOARD FOLLOWING THE HIT OR DROP OF THE REPORTED DEVICE. TO OUR KNOWLEDGE THIS COMPLAINT WAS NOT BEING RELATED TO PATIENT SAFETY. THIS COMPLAINT IS CONSIDERED AS MISUSE. FOR THIS ISSUE AS PER OUR LOCAL PROCEDURE, WE INITIATED NO ACTION.

    Description of Event or Problem · 1

    ERROR 98-0004 UNEXPECTED RESET OCCURRED ON START-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627104 AGILIA VP MC WIFI CA INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other