LUMINOS AGILE MAX

Additional Manufacturer Narrative

INITIAL ACTIONS (CORRECTIVE AND/OR PREVENTIVE): THE SAFETY MECHANISM WAS BYPASSED BY THE CUSTOMER THEMSELVES. NO GENERAL PROBLEM WAS IDENTIFIED FOR THE INSTALLED BASE. MANUFACTURER'S PRELIMINARY RESULTS AND CONCLUSION: THE SAFETY MECHANISM SHOULD NOT HAVE BEEN BYPASSED, SINCE THIS PRESENTS A SAFETY HAZARD IF THE SYSTEM IS USED UNDER THESE CONDITIONS. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL REPORTABLE INFORMATION AND/OR INVESTIGATION COMPLETION.

Description of Event or Problem

SIEMENS HEALTHINEERS WAS NOTIFIED OF AN ISSUE WITH THE LUMINOS AGILE MAX SYSTEM. IT WAS COMMUNICATED THAT THE DIT SIDE COVER WAS BYPASSED DUE TO A MOVEMENT ERROR OF THE BASIC UNIT. THE SAFETY MECHANISM WAS BYPASSED BY THE CUSTOMER THEMSELVES. THERE WAS NO PATIENT OR STAFF INJURY ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE WAS NO INJURY ASSOCIATED WITH THE COMPLAINT ISSUE, IN A WORST-CASE SCENARIO, A MINOR TO SERIOUS INJURY COULD RESULT IF A COLLISION OCCURS BECAUSE OF THE BYPASSED SAFETY MECHANISM AND A PERSON IS CRUSHED AS A CONSEQUENCE.