MIDMARK

Additional Manufacturer Narrative

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.

Description of Event or Problem

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

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.

Additional Manufacturer Narrative

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.