BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    MIDMARK

    MDR report key: 17340930 · Received July 18, 2023

    Report

    Report Number
    1523530-2023-00003
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    June 20, 2023
    Report Date
    July 18, 2023
    Manufacturer
    MIDMARK CORPORATION
    Product Code
    EAZ
    UDI-DI
    00841709106903
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS ISSUED A RETURN AUTHORIZATION TO BE RETURNED TO MIDMARK CORPORATION. DUE TO THE INFORMATION PROVIDED AT THE TIME OF THIS REPORT, MIDMARK CORPORATION BELIEVES THE ROOT CAUSE OF THIS INCIDENT IS SET UP ERROR.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 1 EVENT. THE 1 EVENT REPORTED TO MIDMARK CORPORATION WAS THAT THE LIGHT FLEX ARM HOLDING A MONITOR DETACHED FROM THE CEILING MOUNT TRACK DURING ADJUSTMENT OF THE DEVICE. NO PATIENT OR INJURY WAS INVOLVED IN THIS EVENT. DUE TO PREVIOUS REPORTING OF THIS OR SIMILAR EVENTS, MIDMARK CORPORATION COMPLIED TO REPORT THIS INSTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754832 MIDMARK LED DENTAL FLEX ARM ASSEMBLY EAZ MIDMARK CORPORATION 029-5507-00 00841709106903

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown