BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD32" 4K/UHD MEDICAL DISPLAY

    MDR report key: 12050370 · Received June 23, 2021

    Report

    Report Number
    1221934-2021-01959
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Report Date
    June 11, 2021
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    KQM
    UDI-DI
    00851455007812
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 APPROPRITE. H10 ADDITIONAL NARRATIVE: INVESTIGATION SUMMARY :ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT WHEN CONNECTED THE PRINTER AND PERIPHERAL DEVICES, THE PRINTER WAS NOT ABLE TO PRINT OUT. THE MONITOR SUDDENLY BLACKED OUT. THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. SINCE THE COMPLAINT DEVICE WAS NOT RETURNED, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF THE DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. GIVEN THE LOT NUMBER IS UNKNOWN, A MANUFACTURING RECORD EVALUATION (MRE) REVIEW CANNOT BE PERFORMED. IF THE LOT NUMBER BECOMES AVAILABLE, THE MRE REVIEW WILL BE PERFORMED. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES 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

    UDI: (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 BY THE AFFILIATE IN (B)(6) THAT PREOPERATIVELY TO AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE RAD32" 4K/UHD MEDICAL DISPLAY DEVICE SUDDENLY BLACKED OUT. THERE WAS NO SURGICAL DELAY NOR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951517 RAD32" 4K/UHD MEDICAL DISPLAY DISPLAY KQM DEPUY MITEK LLC US 00851455007812

    Patients

    Seq Age Sex Outcome Treatment
    1