BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AGILIA VP IN

    MDR report key: 11091060 · Received December 29, 2020

    Report

    Report Number
    3000240707-2020-00174
    Event Type
    Malfunction
    Date Received
    December 29, 2020
    Date of Event
    December 1, 2020
    Report Date
    December 29, 2020
    Manufacturer
    FRESENIUS VIAL S.A.S.
    Product Code
    FRN
    PMA / PMN Number
    K121613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INCREMENT KEYS ARE NOT WORKING, PROPERLY CONNECTED BUT STILL PROBLEM NOT SOLVED. DEVICE HISTORY RECORD WAS REVIEWED, NO EVENT LINKED TO THE REPORTED ISSUE WAS OBSERVED. DEVICE LOG WAS NOT PROVIDED THEREFORE REVIEW COULD NOT BE PERFORMED. REPORTED DEVICE WAS NOT SENT BACK TO (B)(4) FOR INVESTIGATION BUT WAS REPAIRED BY FK (B)(4) SERVICE CENTER. THIS COMPLAINT REMAINS AS NOT CONFIRMED DUE TO: THE LACK OF EVIDENCE (LOG, PHOTO WITH SN, VIDEO WITH SN). EQUIPMENT AND/OR PARTS NOT SENT FOR INVESTIGATION. TO OUR KNOWLEDGE NO PATIENTS OR TREATMENTS WERE INVOLVED. THIS COMPLAINT IS ADDED IN OUR TRENDS FOR STATISTICAL ANALYSIS. THIS COMPLAINT IS NOT CONFIRMED. NO ACTION WAS INITIATED FOR THIS ISSUE AS PER OUR LOCAL PROCEDURES. THE TREND IS NORMAL AND REPORTED RISK IS LOWER THAN ESTIMATED RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554478 AGILIA VP IN INFUSION PUMP SYSTEM FRN FRESENIUS VIAL S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other