MAGNETOM VIDA

Additional Manufacturer Narrative

E1: A FACILITY CONTACT NAME AND PHONE NUMBER WERE NOT PROVIDED FOR REPORTING. H3, H6: 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 A PATIENT INJURY ASSOCIATED WITH A MAGNETOM VIDA. IT WAS STATED THAT A PATIENT HAD A BURN MARK ON THE CHEST AT THE LOCATION OF AN ECG LEAD. SIEMEN HEALTHINEERS WAS INFORMED ON (B)(6) 2026 THAT THE PATIENT HAD REDNESS ON THE ABDOMEN AREA AND BLISTERS. THE PATIENT WAS REFERRED TO A PLASTIC SURGEON FOR SURGICAL INTERVENTION. THE PATIENT IS RECEIVING TREATMENT FROM THE HOSPITAL. AS OF THE DATE OF THIS REPORT, ADDITIONAL DETAILS REGARDING THE PATIENT'S CURRENT HEALTH STATUS WERE PROVIDED.