LUCEA 10/40

Description of Event or Problem

ON 22TH MAY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. IT WAS STATED THE SCREW CAP WAS MISSING FROM THE DEVICE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. FURTHER INFORMATION PROVIDED BY GETINGE EMPLOYEE ON 31ST MAY 2023 INDICATED THE COVER WHICH HOLDING THE SCREW WAS BROKEN WITHOUT MISSING PARTICLES. BASED ON ADDITIONAL INPUT FROM GETINGE EMPLOYEE IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED, AS THERE WAS NO MISSING CAP, WHICH WAS INITIALLY CONSIDERED. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE.

Additional Manufacturer Narrative

INITIALLY RECEIVED INFORMATION STATED THE SCREW CAP WAS MISSING FROM THE DEVICE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. FURTHER INFORMATION PROVIDED BY GETINGE EMPLOYEE INDICATED THE COVER WHICH HOLDING THE SCREW WAS BROKEN WITHOUT MISSING PARTICLES. BASED ON ADDITIONAL INPUT FROM GETINGE EMPLOYEE IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED, AS THERE WAS NO MISSING CAP, WHICH WAS INITIALLY CONSIDERED. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE. WE HAVE PERFORMED A ROOT CAUSE EVALUATION INTO THE CLAIMED ISSUE AND CONCLUDED THAT THE INVESTIGATED CUSTOMER PRODUCT COMPLAINT DID NOT CAUSE RISK TO HUMAN LIFE AND IS NOT LIKELY TO HAVE SUCH EFFECT UPON RECURRENCE, PER CURRENTLY AVAILABLE DATA AND KNOWLEDGE. WHEN THE ISSUE OCCURS, THE DEVICE IS NOT UP TO THE MANUFACTURER SPECIFICATION, USUALLY AFTER REPAIR OR REPLACEMENT OF THE COMPONENT THE DEVICE COULD RETURN TO NORMAL USE. IF THE DEVICE IS USED IN ACCORDANCE WITH INSTRUCTION PROVIDED IN USER MANUAL, SUCH AS REGULAR PREVENTIVE MAINTENANCE ANY UNEXPECTED FAILURES SHOULD NOT OCCUR. AFTER REVIEWING THE INFORMATION PROVIDED FOR THE COMPLAINTS INVESTIGATED HEREIN WE HAVE BEEN ABLE TO ESTABLISH THAT THERE IS NO SIGNIFICANT COMPLAINT TREND WITH THIS PRODUCT AND ISSUE TYPE. IT IS NOT LIKELY THAT IT COULD LEAD TO THE SERIOUS INJURY OR DEATH WHEN THE MALFUNCTION REOCCURS. THE CORRECTION OF B5 DESCRIBE EVENT AND PROBLEM DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT AND PROBLEM: ON 22TH MAY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. IT WAS STATED THE SCREW CAP WAS MISSING FROM THE DEVICE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. CORRECTED B5 DESCRIBE EVENT AND PROBLEM: ON 22TH MAY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. IT WAS STATED THE SCREW CAP WAS MISSING FROM THE DEVICE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY. FURTHER INFORMATION PROVIDED BY GETINGE EMPLOYEE ON 31ST MAY 2023 INDICATED THE COVER WHICH HOLDING THE SCREW WAS BROKEN WITHOUT MISSING PARTICLES. BASED ON ADDITIONAL INPUT FROM GETINGE EMPLOYEE IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY AND RISK RELATED, AS THERE WAS NO MISSING CAP, WHICH WAS INITIALLY CONSIDERED. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE.

Description of Event or Problem

ON (B)(6) 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF EXAMINATION LIGHTS - LUCEA 40. IT WAS STATED THE SCREW CAP WAS MISSING FROM THE DEVICE. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF DURING EXAMINATION PROCEDURE MAY CAUSE CONTAMINATION OR SERIOUS INJURY.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO MANUFACTURER.