BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT PLUS INSTRUMENT

    MDR report key: 14117472 · Received April 15, 2022

    Report

    Report Number
    2184009-2022-00080
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Date of Event
    April 1, 2022
    Report Date
    April 15, 2022
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    GKN
    PMA / PMN Number
    K940426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED IMPROPER RESULTS ISSUE WAS NOT VERIFIED DURING SERVICE. TECHNICIAN WAS UNABLE TO CONFIRM THE COMPLAINT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A ACT PLUS INSTRUMENT, IT WAS REPORTED IMPROPER RESULTS OCCURRED. USE OF THE INSTRUMENT WAS UNSPECIFIED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1907517 ACT PLUS INSTRUMENT TIMER, CLOT, AUTOMATED GKN PERFUSION SYSTEMS ACT200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown