EXAMINATION LIGHT F 300, CEILING MOUNT, LED DIMMABLE, DOUBLE-ARM, 24V DC, 100-

Description of Event or Problem

IT WAS REPORTED THAT THE F300 WAS HANGING BY A CABLE AND NEEDED RE-INSTALLED. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

Description of Event or Problem

IT WAS REPORTED THAT THE F300 WAS HANGING BY A CABLE AND NEEDED RE-INSTALLED. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

Additional Manufacturer Narrative

IT WAS REPORTED BY THE FIELD SERVICE TECHNICIAN (FST) THAT THIS EVENT TOOK PLACE IN AN EXAM ROOM IN THE ER AND THERE WAS A COMBATIVE PATIENT IN THE ROOM. THE LIGHT WAS USED AS A WEAPON, AND THE SCREW THAT HOLDS THE ARMS TOGETHER WAS DISCONNECTED BY THE PATIENT. THE FST VISITED THE ACCOUNT AND REPORTED REASSEMBLING THE DEVICE, SECURING THE ARMS WITH A NEW SCREW AND RESTORING FULL FUNCTIONALITY. HOWEVER, THE CUSTOMER WOULD BE ORDERING A REPLACEMENT. THE MANUFACTURING DHR FOR THE DEVICE WAS REVIEWED. THE DOCUMENT SHOWS ALL PASSING RESULTS. ACCORDING TO THE INTAKE INFORMATION, THERE WAS NO ADVERSE EVENT REPORTED AND THIS EVENT OCCURRED OUTSIDE OF SURGERY. THE ROOT CAUSE IS TRACED TO A COMBATIVE PATIENT IN THE ROOM AND LIGHT BEING USED AS A WEAPON, WHICH DOES NOT FOLLOW THE INTENDED USE FOR THIS LIGHT (AS OUTLINED IN THE CHROMOPHARE F300 EXAM LIGHT OPERATING MANUAL). THIS FAILURE MODE HAS NOT EXCEEDED ANY THRESHOLDS AND WILL CONTINUE TO BE MONITORED. IF ANY FURTHER INFORMATION IS RECEIVED, A SUPPLEMENTAL WILL BE FILED.