REVOLUTION

Additional Manufacturer Narrative

BLOCK A: ADDITIONAL PATIENT INFORMATION WAS NOT OBTAINED DUE TO COUNTRY PRIVACY LAWS. AN 87 Y/O FEMALE PATIENT WITH CEREBRAL PALSY WAS UNDERGOING A HEAD-FIRST SCAN. AFTER THE SCAN COMPLETED, THE TABLE WAS MOVING BACK TO HOME POSITION WHEN THE PATIENT'S ARM FELL OFF THE CRADLE AND GOT PINCHED WITH THE TABLE UPPER STRUCTURE. THE LOWER HUMERUS SUSTAINED A SPIRAL OBLIQUE FRACTURE. INVESTIGATION CONCLUDED THERE WAS NO MALFUNCTION OF THE SYSTEM AND THE ROOT CAUSE WAS DETERMINED TO BE UNINTENDED USE ERROR, I.E. PATIENT LIMBS NOT ADEQUATELY SECURED DURING SCANNING. THE USER MANUAL (P/N 5848887-1EN REV 3) PROVIDES INSTRUCTIONS ON APPROPRIATE PATIENT POSITIONING. "TO PREVENT PINCHING OR CRUSHING OF THE PATIENT'S EXTREMITIES, KEEP THE PATIENT'S HANDS AND FEET AWAY FROM THE EDGE OF THE MOVING TABLETOP/CRADLE AND ITS SURROUNDING EQUIPMENT. TO PREVENT PINCHING OR CRUSHING OF THE PATIENT, WATCH THE PATIENT AND EQUIPMENT CAREFULLY AT ALL TIMES DURING TABLE MOVEMENT." THE DESIGN'S RESIDUAL RISK HAS BEEN DETERMINED TO BE REDUCED TO AS FAR AS POSSIBLE AND NO MITIGATIONS ARE AVAILABLE TO SIGNIFICANTLY REDUCE THE RISK FURTHER. GEHC WILL CONTINUE TO TREND SIMILAR EVENTS.

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT SUSTAINED A FRACTURE WHEN THEIR ARM DROPPED OFF THE SIDE OF THE TABLE WHILE EXITING THE BORE AFTER AN EXAM. THERE IS NO INDICATION OF DEVICE MALFUNCTION.

Additional Manufacturer Narrative

LEGAL MANUFACTURER: HCS WSO - 3000 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188. BLOCK A: PATIENT INFORMATION WAS NOT OBTAINED DUE TO COUNTRY PRIVACY LAWS. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.