BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD32" 4K/UHD MEDICAL DISPLAY

    MDR report key: 10264029 · Received July 13, 2020

    Report

    Report Number
    1221934-2020-01796
    Event Type
    Malfunction
    Date Received
    July 13, 2020
    Date of Event
    June 22, 2020
    Report Date
    June 26, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    FWC
    PMA / PMN Number
    K123359
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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: INVESTIGATION SUMMARY: THE DEVICE WAS RECEIVED AND EVALUATED AT THE SERVICE CENTER. THE REPORTED COMPLAINT THAT THE DISPLAY OF THE DEVICE WAS A SNOWY CONDENSED COLOR BAR IMAGE AND DIDN¿T CONVERT TO LIVE VIDEO WHEN CONNECTING A CAMERA, WAS ONLY PARTIALLY CONFIRMED. HOWEVER, WHEN CONNECTED TO 4X3G-SDI, THE SIGNAL FORMAT WAS SET TO "2SAMPLEINTERLEAVE" AND WAS SHOWING A SNOWY LOOKING VERSION OF THE HOST DESKTOP. AFTER ADJUSTING THE SETTING TO "SQUARE DIVISION", THE IMAGE CLEARED UP AND DISPLAYED AS NORMAL. NO OTHER INPUTS SHOWED ANY SYMPTOMS THAT RESEMBLE THE REPORTED COMPLAINT. ALSO A SMALL SCRATCH WAS FOUND IN THE LOWER RIGHT CORNER OF THE FRONT GLASS. HOWEVER, THE COSMETIC REPAIRS WERE DECLINED BY THE CUSTOMER. THE DEVICE WAS TESTED AND FOUND TO BE FUNCTIONING ACCORDING TO SPECIFICATIONS. THE INCORRECT SOFTWARE SETTING ON THE DEVICE WOULD HAVE CAUSED THE COMPLAINT REPORTED BY THE CUSTOMER, HOWEVER, SINCE IT COULD NOT BE FULLY DUPLICATED DURING EVALUATION, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. THE SCRATCH ON THE FRONT GLASS CAN BE ATTRIBUTED TO USER MISHANDLING OF THE DEVICE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [SERIAL NUMBER : (B)(6)], 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 · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INSPECTION OF THE RAD32" 4K/UHD MEDICAL DISPLAY DEVICE RETURNING FROM TRIAL, IT WAS OBSERVED THAT THE DISPLAY WAS A SNOWY CONDENSED COLOR BAR IMAGE WHICH DID NOT CONVERT TO LIVE VIDEO WHEN CONNECTING A CAMERA. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726360 RAD32" 4K/UHD MEDICAL DISPLAY EDNOSCOPIC VIDEO IMAGE SYSTEM FWC DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1