BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    242326

    MDR report key: 9933965 · Received April 8, 2020

    Report

    Report Number
    1221934-2020-01096
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    March 12, 2020
    Report Date
    March 12, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    FCW
    UDI-DI
    00817613020543
    PMA / PMN Number
    K123359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: CORRECTION: D10: THE DATE DEVICE RETURNED TO MANUFACTURER HAS BEEN UPDATED TO REFLECT THE CORRECT INFORMATION. INVESTIGATION SUMMARY ==> THE DEVICE WAS RECEIVED AND EVALUATED AT THE SERVICE CENTER. THE REPORTED COMPLAINT THAT THE DEVICE DOES NOT SHUT DOWN APPROPRIATELY WAS UNABLE TO BE CONFIRMED. SYSTEM BOOTED INTO SOFTWARE VERSION 1.4.0. IT WAS POSSIBLE TO GET VIDEO ON ALL CHANNELS WITH NO ISSUES. ALSO THE SYSTEM WAS SHUT DOWN WITHOUT ANY ISSUES WITHIN THE INTENDED 5 SECONDS OF TIME. IT WAS FOUND THAT THE REAR PORTS WERE SLIGHTLY TOO FAR IN THE CHASSIS. THE HDMI PORT HAD TO BE PLUGGED IN PRECISELY TO GET VIDEO OUT. AFTER MAKING SURE THE MOTHERBOARD WAS FULLY SECURED AND PRESSED AGAINST THE IO PORTS THE HDMI HAD NO ISSUES. THE FRONT LAMINATE POWER LED WAS NO LONGER LIT UP. THE LAMINATE CABLES WERE UNPLUGGED AND LUGGED WITH NO RESULT. THE FRONT LAMINATE POWER LED WAS NOT FUNCTIONING AND WAS REPLACED. SINCE THE REPORTED CONDITION IS NOT CONFIRMED,THE ROOT CAUSE FOR THE REPORTED FAILURE CANNOT BE DETERMINED. GIVEN THE INFORMATION PROVIDED, WE CANNOT DETERMINE A DEFINITIVE ROOT CAUSE FOR THE DEFECTIVE LAMINATE POWER LED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (SERIAL NUMBER : 0119123C), AND NO NON-CONFORMANCES WERE IDENTIFIED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. DEPUY MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: D10, H3, H6: THE ACTUAL DEVICE HAS BEEN RETURNED AND IS CURRENTLY PENDING EVALUATION. ONCE RELIABILITY ENGINEERING EVALUATES THE DEVICE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT ACCORDINGLY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY CLINICAL EVALUATOR VIA EMAIL, THAT IT APPEARS TO BE A GLITCH IN AN EVO4K VIDEO RECORDER, PICTURE ON SCREEN IS OFF, DOES NOT SHUT DOWN APPROPRIATELY. NO PATIENT INVOLVEMENT OR SURGICAL DELAY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402155 242326 EVOLUTION4K FCW DEPUY MITEK LLC US EVO4K220 00817613020543

    Patients

    Seq Age Sex Outcome Treatment
    1