MalfunctionDXO
TRUWAVE
Received May 28, 2026
Report 2015691-2026-15609 · MDR key 25322003
Device
Product problems
- Detachment of Device or Device Component
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL PREMARKET SUBMISSION: K171996 THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.
Description of Event or Problem
IT WAS REPORTED THAT A PRESSURE MONITORING DEVICE BECAME LOOSE AND DISCONNECTED FROM AN EVD SYSTEM. IT IS UNKNOWN WHEN THE ISSUE OCCURRED, BUT THERE WERE NO ALLEGATIONS OF PATIENT INJURIES.