870 TANDEM

Additional Manufacturer Narrative

UDI NUMBER: (B)(4). LEGAL MANUFACTURER: HCS HAIFA FI - 4 HAYOZMA ST. ISRAEL TIRAT HACARMEL HAIFA, 30200. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

Description of Event or Problem

DURING SERVICING OF AN 870 TANDEM SYSTEM, WHILE ASSEMBLING THE REAR CT GANTRY COVER, THE FIELD ENGINEER SUSTAINED A LACERATION AFTER CONTACTING AN INNER PART OF THE COVER. THE RESULTING LACERATION ON THE LEFT MIDDLE FINGER REQUIRED SUTURES.

Additional Manufacturer Narrative

DURING A SERVICE EVENT THE FE WAS TROUBLESHOOTING AN ISSUE THAT REQUIRED ACCESS TO THE BASE OF THE GANTRY FOR INSPECTION. AFTER HIS INSPECTION COMPLETED, HE BEGAN REINSTALLING THE REAR BASE GANTRY COVERS BACK INTO PLACE. WHILE ADJUSTING THE LEFT REAR BASE COVER, HIS HAND CONTACTED THE BOTTOM EDGE OF THE REAR CT BORE COVER AND HE SUSTAINED A FINGER LACERATION REQUIRING SUTURES. NO MALFUNCTION WAS REPORTED. GE HEALTHCARE'S INVESTIGATION DETERMINED THAT THE ROOT CAUSE WAS INCIDENTAL HAND FORCE/IMPACT WITH BOTTOM EDGE OF THE GANTRY REAR COVER DURING MANUAL HANDLING AND ALIGNMENT. THE RISK ANALYSIS DETERMINED THAT NO ADDITIONAL MITIGATIONS ARE AVAILABLE TO REDUCE THE RISK, AND THE RISK HAS BEEN REDUCED AS FAR AS POSSIBLE. NO FURTHER ACTIONS ARE PLANNED BY GE HEALTHCARE.