HUGO¿ RAS SYSTEM
Received Jul 6, 2026 · Event occurred Jul 2, 2026
Report 1219930-2026-04274 · MDR key 25719341
Device
Product problems
- Use of Device Problem
- Complete Loss of Power
- No Tactile Prompts/Feedback
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT, PRE-OPERATIVELY, THE AC POWER CABLES WERE DISCONNECTED FROM THE UNIT. AFTER POWER REMOVAL, THE LOWER BATTERY REMAINED ACTIVE AND CONTINUED TO DISCHARGE WHILE THE SYSTEM WAS UNPLUGGED. THE BATTERY LEVEL DROPPED TO APPROXIMATELY 70 PERCENT. THE UNIT WAS SET TO RECHARGE; HOWEVER, DURING THE RECHARGE PERIOD, THE POWER BUTTON (LIGHT EMITTING DIODE) LED WAS NOT OBSERVED PULSING. AFTER THE SYSTEM RECHARGED TO 100%, THE SYSTEM WAS MANUALLY REBOOTED AND OPERATED PROPERLY. NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.