ARTIS ZEE CEILING

Additional Manufacturer Narrative

SIEMENS IS CONDUCTING A THOROUGH INVESTIGATION OF THE REPORTED EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE ARTIS ZEE CEILING SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, NO X-RAY RELEASE WAS AVAILABLE. THE PATIENT WAS RELOCATED TO COMPLETE THE PROCEDURE ON AN ALTERNATIVE DEVICE. SIEMENS IS NOT AWARE OF ANY ADVERSE EFFECT ON THE HEALTH STATUS OF THE INVOLVED PATIENT.