MIDMARK

Description of Event or Problem

IT WAS REPORTED TO MIDMARK CORPORATION THAT THE WELDMENT ON A MONITOR DOWN TUBE OF A DENTAL LIGHT BROKE, AND THE MONITOR WAS SUSPENDED BY THE WIRE HARNESS. NO USER OR PATIENT INVOLVEMENT OR INJURY REPORTED WITH THIS INSTANCE. DUE TO PREVIOUS REPORTING OF THIS OR SIMILAR LIGHT FALLING EVENTS, MIDMARK COMPLIED TO REPORT THIS INSTANCE.

Additional Manufacturer Narrative

AT THE TIME OF THIS REPORT, IT IS KNOWN THAT THE MONITOR DOWN TUBE WELDMENT WAS FOUND TO BE HANGING BY THE WIRE HARNESS. NO USER OR PATIENT INVOLVEMENT OR INJURY NOTED IN THIS INSTANCE. SINCE THE BUILD DATE OF THIS DEVICE, DESIGN CORRECTION(S) HAVE BEEN PUT INTO PLACE TO PREVENT THE FAILURE. THE DEVICE WELDMENT HAS BEEN SCHEDULED FOR SERVICE AND REPAIR FOR USE.