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Description of Event or Problem

IT WAS REPORTED THAT A PATIENT SUSTAINED AN ARM FRACTURE WHEN THEIR ARM (WHICH WAS NOT SECURED WITH PATIENT STRAPS) FELL OFF THE TABLE WHILE THE TABLE WAS MOVING INTO THE BORE. THERE IS NO INDICATION OF DEVICE MALFUNCTION.

Additional Manufacturer Narrative

UDI : (B)(4). LEGAL MANUFACTURER: HCS HINO - 7-127 ASAHIGAOKA 4-CHOME JAPAN HINO-SHI TOKYO, 191-8503. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. H3 OTHER TEXT : DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

Additional Manufacturer Narrative

IT WAS REPORTED THAT WHEN A PATIENT WAS BEING DRIVEN INTO THE BORE FOR SCANNING, THEIR RIGHT ARM FELL BEYOND THE SIDE OF THE TABLE AND IMPACTED THE GANTRY. THE PATIENT WAS NONVERBAL AND HAD RIGHT ARM PARALYSIS AND THE TECHNOLOGIST DID NOT SECURE THE PATIENT'S ARM WITH SAFETY STRAPS BEFOREHAND. THE PATIENT SUSTAINED A HUMERAL BONE FRACTURE. EXISTING DESIGN MITIGATION'S INCLUDE TABLE DRIVE FORCE LIMITS, E-STOPS, TOUCH SENSORS, PATIENT POSITIONING STRAPS, AND WARNINGS IN THE USER MANUAL. INVESTIGATION AND RISK ASSESSMENT HAVE CONCLUDED THAT CAPA IS NOT REQUIRED BECAUSE THE DESIGN'S RESIDUAL RISK IS AT AFAP AND NO MITIGATION'S ARE AVAILABLE TO SIGNIFICANTLY REDUCE THE RISK FURTHER. GEHC WILL CONTINUE TO TREND SIMILAR EVENTS. NO FURTHER ACTION IS PLANNED.