BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    MIDMARK

    MDR report key: 17789969 · Received September 21, 2023

    Report

    Report Number
    1523530-2023-00004
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    August 10, 2023
    Report Date
    September 10, 2024
    Manufacturer
    MIDMARK CORPORATION
    Product Code
    KZF
    UDI-DI
    00841709106828
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MIDMARK CORPORATION HAS REQUESTED THAT THE LIGHT BE RETURNED FOR EVALUATION, AND A SERVICER HAS BEEN DISPATCHED TO REPLACE A NEW LIGHT WITHIN THE FACILITY. AT THE TIME OF THIS REPORT, MIDMARK CORPORATION HAS RECEIVED THE RETURNED LIGHT.

    Additional Manufacturer Narrative · 0

    AT THE TIME OF THE INTIAL REPORT OF THIS INSTANCE, THE LIGHT HAD NOT BEEN RETURNED TO MIDMARK CORPORATION. SINCE THAT TIME, THE LIGHT HAS BEEN RETURNED, EVALUATED, AND A FORMAL INVESTIGATION HAS BEEN PERFORMED. RESULTS FROM THE INVESTIGATION CONFIRMED THAT THE PROCESS CHANGE TO THIS DEVICE THAT HAS BEEN PUT IN PLACE WILL PREVENT THIS FAILURE. NO FURTHER ACTION IS NECESSARY.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 1 EVENT. THE 1 EVENT REPORTED TO MIDMARK CORPORATION WAS THAT A LIGHT ARM OF A DUAL CEILING LIGHT DETACHED AT THE BALL JOINT AND FELL. NO PATIENT OR INJURY WAS INVOLVED IN THIS EVENT. DUE TO REPORTING OF THIS OR SIMILAR EVENTS, MIDMARK CORPORATION COMPLIED TO REPORT THIS INSTANCE.

    Description of Event or Problem · 0

    THE ORIGINAL SUBMISSION, MFG REPORT # 1523530-2023-00004 SUBMITTED SEPT. 21, 2023, SUMMARIZED 1 EVENT REPORTED TO MIDMARK CORPORATION THAT A LIGHT ARM OF A DUAL CEILING LIGHT DETACHED AT THE BALL JOINT AND FELL. NO PATIENT OR INJURY WAS INVOLVED IN THIS EVENT. DUE TO REPORTING OF THIS OR SIMILAR EVENTS, MIDMARK CORPORATION COMPLIED TO REPORT THIS INSTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1518370 MIDMARK 255 DUAL CEILING LIGHT KZF MIDMARK CORPORATION 255-023 00841709106828

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown