Masimo Sedline ModuleRecalls & reported problems
Philips Medizin Systeme Böblingen GmbH · Masimo SedLine Plug-in Module for IntelliVue Patient Monitors to connect the Masimo SedLine Measurement Device (989803203051) · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838086678), received between Dec 10, 2024 and Dec 10, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Defective Alarm” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Defective Alarm1
Patient problems
- Awareness During Anesthesia1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2024Defective Alarm; Defective Alarm
DURING AN OPERATION ON A PATIENT MONITORED WITH A PHILIPS MONITOR ON WHICH A MASIMO SEDLINE MODULE WAS CONNECTED, THE PATIENT AWOKE DURING THE INTERVENTION WITHOUT ANY ALARM SOUNDING. THE PATIENT REMAINED AWARE DURING THE REST OF THE INTERVENTION AND NO ALARM SOUNDED TO INFORM THE MEDICAL STAFF THAT THE PATIENT WAS AWARE. THE LOGS OF THE DEVICE WERE RECOVERED AND SENT FOR ANALYSIS. ADDITIONAL INFORMATION IS REQUESTED FOR FURTHER CLARIFICATION AND ASSESSMENT OF THE CUSTOMER¿S ALLEGED HARM(S). THIS MEASUREMENT IS NOT INTENDED TO BE USED AS A STANDALONE DETERMINATION OF DEPTH OF ANESTHESIA, BUT INSTEAD TO BE USED AS AN ADJUNCT DEVICE DURING PATIENT ASSESSMENT. THE DEVICE MUST BE USED IN CONJUNCTION WITH THE PATIENT¿S CLINICAL SIGNS AND SYMPTOMS. BASED ON THIS INFORMATION, THERE WERE NO CLINICAL SIGNS OR SYMPTOMS OF THE PATIENT'S ANESTHESIA AWARENESS AND THERE WAS NO PHYSICAL HARM TO THE PATIENT. PHILIPS CANNOT DETERMINE WHETHER THERE WAS A DEVICE DEFICIENCY OR A PATIENT CONDITION, USE, OR ENVIRONMENTAL COMPONENT TO THE REPORTED EVENT; THEREFORE, THIS EVENT WILL BE CONSERVATIVELY CONSIDERED TO BE A SERIOUS INJURY AT THIS TIME DUE TO THE PSYCHOLOGICAL TRAUMA ASSOCIATED WITH ANESTHESIA A
Patient problems: Awareness During Anesthesia; No Clinical Signs, Symptoms or Conditions
MAUDE report 20892671 ↗
Other Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) devices
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- IntelliVue Multi-Measurement Module X3 IntelliVue X3Philips Medizin Systeme Böblingen GmbH · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)1 recall19 deaths1,172 reports
- Patient Information Center IXPhilips Medical Systems Hsg · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)82 deaths941 reports
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- Tempus Pro 00-1024-RRemote Diagnostic Technologies Limited · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)5 recalls541 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.