REVOLUTION

Additional Manufacturer Narrative

LEGAL MANUFACTURER: HCS WSO - 3000 N GRANDVIEW BLVD. USA WAUKESHA, WI 53188. BLOCK A: FE 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.

Description of Event or Problem

IT WAS REPORTED THAT, DURING INSTALLATION OF THE SYSTEM, A FIELD ENGINEER'S THUMB GOT PINCHED IN THE TABLE SPRING, CAUSING A WOUND THAT WAS TREATED WITH SURGERY.

Additional Manufacturer Narrative

BLOCK A: ADDITIONAL PATIENT INFORMATION WAS NOT OBTAINED DUE TO COUNTRY PRIVACY LAWS. GE HEALTHCARE HAS COMPLETED ITS INVESTIGATION. DURING SYSTEM INSTALLATION, THE FE LOWERED THE TABLE AND HEARD A NOISE COMING FROM THE ELEVATION SPRING. HE OBSERVED THE SPRING COMPRESSED INTO A C SHAPE; DISPLACED FROM ITS LANDING KNOB. HE RAISED THE TABLE AND THE SPRING RETURNED TO THE KNOB BUT WAS SLIGHTLY MISALIGNED. WHEN HE PUSHED THE SPRING BY HAND, IT EXTENDED AND STRUCK HIS THUMB; CAUSING A LACERATION THAT WAS TREATED SURGICALLY. INVESTIGATION CONCLUDED THAT THE FIELD ENGINEER PERFORMED A SERVICE INTERVENTION NOT SPECIFIED IN THE INSTALLATION MANUAL AS SPRING ADJUSTMENT IS NOT PART OF THE INSTALLATION PROCEDURE. FOLLOWING A COMPREHENSIVE REVIEW OF THE DESIGN, MANUFACTURING, TRANSPORTATION, CUSTOMER-SITE UNPACKING, AND FIELD ENGINEER INSTALLATION PROCESSES, NO FACTORS WERE IDENTIFIED THAT COULD HAVE CAUSED THE TABLE SPRING TO BECOME MISALIGNED. THEREFORE, THE PRODUCT ROOT CAUSE REMAINS UNDETERMINED. 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. NO FURTHER ACTIONS ARE PLANNED BY GE HEALTHCARE.