BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDMARK

    MDR report key: 22830877 · Received August 18, 2025

    Report

    Report Number
    1523530-2025-00007
    Event Type
    Malfunction
    Date Received
    August 18, 2025
    Date of Event
    August 8, 2025
    Report Date
    August 18, 2025
    Manufacturer
    MIDMARK CORPORATION
    Product Code
    EAZ
    UDI-DI
    00841709106897
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION HAS BEEN PROVIDED TO MIDMARK CORPORATION REGARDING THIS INSTANCE AT THE TIME OF THIS REPORT. SINCE THE BUILD DATE OF THIS DEVICE, DESIGN CORRECTION(S) HAVE BEEN PUT INTO PLACE TO PREVENT THE FAILURE. IF FURTHER INFORMATION IS PROVIDED, A FOLLOW UP REPORT WILL BE MADE IF NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MIDMARK CORPORATION THAT ON (B)(6) 2025, A LIGHT FLEX ARM ASSEMBLY FELL FROM ITS TROLLEY. NO INJURY HAS BEEN REPORTED. DUE TO PREVIOUS REPORTING OF LIKE INSTANCES, MIDMARK CORPORATION COMPLIED TO REPORT THIS INSTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543122 MIDMARK LIGHT FLEX ARM ASSEMBLY EAZ MIDMARK CORPORATION 029-4857-00 00841709106897

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown