SEDLINE SEDITATION MONITOR
Received Jun 12, 2026 · Event occurred Jan 1, 2026
Report 3019388613-2026-00306 · MDR key 25481452
Device
Product problems
- Failure to Sense
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
MASIMO HAS REACHED OUT TO THE CUSTOMER TO REQUEST THE RETURN OF THE DEVICE. THE DEVICE HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF THE DEVICE IS RETURNED FOR EVALUATION OR NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED. SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. HEALTH EFFECT IMPACT CODE: NO ADVERSE EVENT; NO PATIENT IMPACT H3 OTHER TEXT : DEVICE NOT RETURNED
Description of Event or Problem
THE CUSTOMER REPORTED "WE ARE SEEING 3-5 SEDLINE CABLE FAILURES A WEEK THAT IMPACT SURGERY IN REAL TIME. THE SEDLINE MODULE AND CABLE EXPERIENCE FAILURES THAT CAUSE THE MD TO BE UNABLE TO EVALUATE THE PATIENT'S DEPTH OF ANESTHESIA. THERE WAS NO PATIENT IMPACT OR CONSEQUENCE REPORTED.
Remedial action
- Other