BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACT PLUS INSTRUMENT

    MDR report key: 19728938 · Received July 12, 2024

    Report

    Report Number
    2184009-2024-00405
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    June 13, 2024
    Report Date
    July 12, 2024
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    GKN
    PMA / PMN Number
    K940426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION SUMMARY: THE REPORTED DEVIATION IN THE TEST RESULTS WAS NOT VERIFIED DURING PRELIMINARY ANALYSIS. DURING PRELIMINARY ANALYSIS THE INSTRUMENT BOOTED UP NORMALLY. SERVICE TECHNICIAN CLEANED DUST INSIDE INSTRUMENT. THE INSTRUMENT IS NOT REPAIRABLE AND WILL BE RETURNED TO CUSTOMER. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN ACT PLUS INSTRUMENT, IT WAS REPORTED THAT THERE WAS A DEVIATION IN THE TEST R ESULTS. THE USE OF THE INSTRUMENT WAS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341424 ACT PLUS INSTRUMENT TIMER, CLOT, AUTOMATED GKN PERFUSION SYSTEMS ACT200

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown