OXIMETER
Received Mar 24, 2017 · Event occurred Jan 31, 2017
Report 6431480 · MDR key 6431480
Device
Generic name
Oximeter
Manufacturer
Ge HealthcareProduct problems
- Disconnection
- Incorrect, Inadequate or Imprecise Result or Readings
- Device Displays Incorrect Message
Patient
1 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
PATIENT WAS BEING MONITORED ON NSATX SECONDARY SPO2 MODULE ON HER LEFT WRIST. MODULE SHOWED PULSE SEARCH WITH WAVEFORM BUT NOT VALUE, 3 DASHES IN PLACE OF VALUE, AND 3 STARS. THIS CONTINUED FOR 2-3 MINUTES THEN READING RETURNED BUT HEART READING FROM SPO2 DID NOT MATCH ELECTROCARDIOGRAM (ECG). HEART RATE (HR) ON ECG WAS 167, SPO2 HR WAS 180 AND MONITOR SHOWED MOTION DETECTED. THIS CONTINUED FOR ABOUT 5 MINUTES THEN MONITOR READ PROBE OFF, FLAT LINE FOR WAVEFORM, NO VALUE,AND 3 DASHES. IT CONTINUED TO READ THIS FOR 2 MINUTES. SWITCHED BACK TO PATIENT DATA MODULE (PDM) AND READ WELL. ABOUT AN HOUR LATER, THE PDM READ PROBE OFF, NO VALUE, AND 3 DASHES, AND FLAT LINE FOR WAVEFORM. REMOVED NSATX FROM ROOM AND SAVED FOR INVESTIGATION NEEDS.