APRON, LEADED

Additional Manufacturer Narrative

H3: THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER, AND NO IMAGES OR PHYSICAL EVIDENCE ARE AVAILABLE FOR EVALUATION. THEREFORE, THIS EVENT IS REPORTED BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER. THE CUSTOMER REPORTED THAT THE DEVICE FAILED FLUOROSCOPY TESTING; HOWEVER, THE REPORTED ISSUE COULD NOT BE CONFIRMED. AN INVESTIGATION COULD NOT BE FULLY PERFORMED DUE TO THE LACK OF RETURNED PRODUCT, SUPPORTING DOCUMENTATION, OR ADDITIONAL INFORMATION. A DEVICE HISTORY RECORD (DHR) IS NOT AVAILABLE FOR REVIEW. THE DEVICE IS REPORTED TO HAVE BEEN MANUFACTURED IN 2011. GIVEN THE AGE OF THE PRODUCT, POTENTIAL DEGRADATION DUE TO NORMAL WEAR OVER TIME CANNOT BE EXCLUDED AS A CONTRIBUTING FACTOR. AT THIS TIME, THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED. THERE IS NO CONCLUSIVE EVIDENCE OF A MANUFACTURING OR DESIGN NONCONFORMITY CONTRIBUTING TO THE REPORTED COMPLAINT. ALL COMPLAINTS ARE TRENDED AND REVIEWED IN ACCORDANCE WITH THE MANUFACTURER¿S QUALITY SYSTEM PROCEDURES, AND ANY ADVERSE TRENDS WILL BE FURTHER EVALUATED AND ADDRESSED AS APPROPRIATE. MANUFACTURER REFERENCE FILE: (B)(4).

Description of Event or Problem

ZERO GRAVITY THE PHYSICS YEARLY FLUOROSCOPY CHECK FAILED THE APRON ON THAT FLOOR MOUNTED SYSTEM.