ZERO GRAVITY FLOOR SYSTEM 6.5' ARM

Additional Manufacturer Narrative

H3: WITHOUT THE RETURN OF THE DEVICE AND ADDITIONAL INFORMATION, THE COMPLAINT CANNOT BE CONFIRMED, NOR CAN ROOT CAUSE BE POSITIVELY DETERMINED. THE ROOT CAUSE IS FOR SPLIT IN THE LEAD IS UNKNOWN AT THIS TIME. THE BODY SHIELD IS 10 YEARS OLD, SO IT IS UNLIKELY THAT A MANUFACTURING ISSUE CONTRIBUTED TO THE FAILURE. THERE WAS NO PATIENT OR CAREGIVER INJURY REPORTED AS A RESULT OF THIS EVENT. AT THIS TIME THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. PER THE INSTRUCTIONS FOR USE (IFU) ¿A THOROUGH INSPECTION OF EQUIPMENT SHOULD BE PERFORMED, AFTER EACH SERVICE CALL, PRIOR TO RELEASING THE EQUIPMENT FOR USE.¿ ADDITIONALLY, ¿THE ZERO-GRAVITY SYSTEM REQUIRES ANNUAL PREVENTATIVE MAINTENANCE, INSPECTION, AND GENERAL CLEANING THROUGHOUT ITS LIFE.¿ MANUFACTURER REFERENCE FILE:(B)(4).

Description of Event or Problem

1/15/26-CUSTOMER ASKED FOR QUOTE TO REPLACE THE ZERO GRAVITY BODY SHIELD AS IT DID NOT PASS THE X-RAY CHECK AS IT WAS DISCOVERED THAT THERE IS A LARGE SPLIT IN THE LEAD MODEL: ZGM-6-5H SERIAL#: (B)(6) MANUFACTURED 11-2016