NEUROMONITOR BASIC KIT
Received Jul 17, 2026 · Event occurred Jun 25, 2026
Report 3013886523-2026-00171 · MDR key 25855310
Device
Product problems
- No Device Output
Patient
Not reported
- Insufficient Information
Narrative
Description of Event or Problem
A FACILITY REPORTED A MICROSENSOR (ID 826631) WAS USED TO PERFORM AN EMERGENCY SURGERY FOR INTRACRANIAL PRESSURE (ICP) MONITORING ON (B)(6) 2026, AND INITIAL READING WERE NORMAL. ON (B)(6) 2026, THE DEVICE PERSISTENTLY ALARMED WITH ELEVATED VALUES, FOLLOWED BY THE ICP MONITOR DISPLAYING "MICROSENSOR NOT DETECTED." THE ENGINEERS WERE CONTACTED AND TROUBLESHOOTING STEPS (INCLUDING REPLACING THE CABLE AND TESTING WITH A BORROWED ICP MONITOR FROM ANOTHER HOSPITAL) WERE PERFORMED, BUT THE MICROSENSOR REMAINED UNDETECTABLE. THE MICROSENSOR WAS REMOVED AND WAS NOT REPLACED.
Additional Manufacturer Narrative
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.