LUCEA LED®

Additional Manufacturer Narrative

THE INITIAL REPORTER WAS (B)(6) HOSPITAL. INITIAL REPORTER: (B)(6). EVENT SITE NAME: (B)(6). EVENT SITE POSTAL CODE: (B)(6). EVENT SITE TELEPHONE: (B)(6). BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHTS DID NOT MEET ITS SPECIFICATION, SINCE PAINT PEELING COULD BE CONSIDERED AS TECHNICAL DEFICIENCIES, AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. IT IS UNKNOWN IF CLAIMED DEVICES WERE OR WERE NOT BEING USED FOR PATIENT TREATMENT OR DIAGNOSIS WHEN THE EVENT TOOK PLACE. A ROOT CAUSE ANALYSIS FOR PAINT PEELING PROBLEM WAS PERFORMED BY SUBJECT MATTER EXPERTS AND CONCLUDED THAT ALL MAQUET SAS PRODUCTS COMPLY WITH: - IEC 60601-1 ED. 2.0 & ED. 3.0 GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE. - IEC 60601-2-41 PARTICULAR REQUIREMENTS FOR THE SAFETY OF SURGICAL LUMINAIRES AND LUMINAIRE FOR DIAGNOSIS. - PAINT DEFINITION PFC066. THIS PROCEDURE DEFINES MAQUET SAS¿S REQUIREMENTS FOR ALL PAINTED PARTS. - DISINFECTION PRODUCTS TEST: THE AIM OF THESE TESTS IS TO DETECT ANY INCOMPATIBILITY WITH DISINFECTANT. THE PAINT CHIP OR PAINT DAMAGES ARE DUE TO: IMPACTS, COLLISIONS (ABNORMAL USE). THE OPERATING MANUAL INCLUDES THE INSTRUCTIONS TO PRE-POSITION THE ARMS PRIOR TO USE, IN ORDER TO PREVENT DAMAGES. TO PREVENT ANY SIMILAR INCIDENT, IT IS RECOMMENDED TO AVOID THE COLLISIONS BETWEEN DEVICES. VISUAL INSPECTIONS DURING THE CLEANING ALLOW TO DETECT THE PAINTING DEFECT, WE RECOMMEND PERFORMING CORRECTIVE MAINTENANCE TO RECTIFY THE DEFAULT AFTER ITS DETECTION. MINOR PAIN CHIP CAN BE REPAIRED WITH TOUCH UP PAINT, NEVERTHELESS THE PARTS IMPACTED BY SERIOUS DAMAGE MUST BE REPLACED. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

Description of Event or Problem

GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - LUCEA 50. THE DESIGNATED COMPLAINT UNIT EMPLOYEE CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE THAT PAINT WAS CHIPPING OFF ON SPRING ARM. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.