Case serial: SCH-2022-01-003
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Title: Anesthesia Deepness Brain Monitoring (ABDM) system & ABDM electrode sensor
- A 80-year-old female patient with acute cholangitis.
- The patient was in preparation for general anesthesia.
- Before starting general anesthesia, the ADBM electrode sensor (the sensor) was applied to the patient’s forehead.
- The ADBM system failed to display the EEG signal on its monitor.
- The nurse confirmed that the expiration date of the sensor had not passed.
Post-event management & Health effect
- The electrode sensor was replaced with another sensor of the same lot and it worked properly.
- Nurses are experiencing frequent sensor detection errors, especially in older patients. They assume that the skin condition may have an impact, so particular attention is payed when attaching the sensor to elderly patients.
Investigations (Cause, Improvements)
- The quality manager of the manufacturer received the problematic sensor from the user.
- When the problematic sensor was tested by connecting it to an ADBM system by the manufacturer, the system detected the signal normally.
- The quality manager checked the hydro-gel status of other products in the same lot and found that it conformed to the manufacturer's manufacturing standards.
Select the most appropriate IMDRF code for the description.