MOBILETT ELARA MAX

Description of Event or Problem

SIEMENS HEALTHINEERS WAS NOTIFIED OF AN ISSUE WITH THE MOBILETT ELARA MAX SYSTEM. IT WAS COMMUNICATED THAT THE GROUNDING CONNECTION IN THE CABLE WINCH PLUG IS INSUFFICIENT. USUALLY, THIS KIND OF PLUG (FRENCH-TYPE POWER PLUG) IS EQUIPPED WITH TWO METAL TABS THAT CONTACT THE GROUNDING PRONGS ON THE SOCKET. THIS ALLOWS THE ENTIRE METAL STRUCTURE TO CONNECT TO THE GROUNDING WIRE. IN THIS CASE ONLY ONE OF THESE METAL TABS WAS AVAILABLE AND SO THE GROUNDING FUNCTION WAS NOT FULLY ENSURED. IN CASE OF A SECOND FAULT CONDITION AT THE SYSTEM, THE CURRENT LEAKAGE CANNOT BE PROPERLY DISCHARGED THROUGH THE GROUND WIRE AND THUS AN ELECTRIC SHOCK MAY BE POSSIBLE. 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 SERIOUS INJURY OR DEATH COULD RESULT DUE TO ELECTRIC SHOCK.

Additional Manufacturer Narrative

E1: THE REPORTER¿S CONTACT NAME AND PHONE NUMBER WERE NOT PROVIDED FOR REPORTING PURPOSES. H3, H6: INITIAL ACTIONS (CORRECTIVE AND/OR PREVENTIVE): NO GENERAL PROBLEM HAS BEEN DETECTED FOR THE INSTALLED BASE WHICH REQUIRES IMMEDIATE ACTION. MANUFACTURER'S PRELIMINARY RESULTS AND CONCLUSION: THE ROOT CAUSE IS CURRENTLY UNKNOWN AND IS UNDER INVESTIGATION. SIEMENS HEALTHINEERS WILL SUBMIT A SUPPLEMENTAL REPORT TO THE FDA UPON COMPLETION OF THE INVESTIGATION.