MOBILETT MIRA MAX
Received May 6, 2026 · Event occurred Apr 23, 2026
Report 3004977335-2026-00076 · MDR key 25093076
Device
Product problems
- Key or Button Unresponsive/not Working
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
SIEMENS HEALTHINEERS WAS NOTIFIED OF AN ISSUE WITH THE MOBILETT MIRA MAX SYSTEM. IT WAS COMMUNICATED THAT THE EMERGENCY STOP BUTTON WAS BROKEN. ADDITIONAL INFORMATION PROVIDED BY THE SERVICE TECHNICIAN STATED THAT A SMALL PIECE OF PLASTIC WAS PREVENTING THE EMERGENCY STOP BUTTON FROM BEING FULLY PRESSED DOWN. THIS ISSUE COULD RESULT IN THE EMERGENCY STOP NOT BEING ACTIVATED WHEN PRESSED. ALTHOUGH THERE WAS NO INJURY ASSOCIATED WITH THE COMPLAINT ISSUE, IN A WORST-CASE SCENARIO, NOT BEING ABLE TO ACTIVATE THE EMERGENCY STOP COULD RESULT IN SERIOUS INJURY.
Additional Manufacturer Narrative
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. THE INVESTIGATION IS ONGOING. SIEMENS HEALTHINEERS WILL SUBMIT A SUPPLEMENTAL REPORT TO THE FDA UPON COMPLETION OF THE INVESTIGATION.