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U.S. Department of Health and Human Services

Medsun Reports
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Type of Device:
MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
Device Brand Name:
CARESCAPE B650
Device Manufacturer's Name:
GE Healthcare Finland Oy
Date of this Report:
(mm/dd/yyyy)
10/22/2021
Describe the Event
or Problem:
RN attempted to perform an ECG using the GE Carescape B650 12 Lead Monitoring functionality. The 12 Lead cable was attached to the monitor and the electrodes were appropriately placed on the patient by an experienced RN. The RN attached the cable to the electrodes and wavelengths appeared on the screen, but the wavelengths were very random, and a usable waveform was never able to be captured. An ECG cart was obtained, which immediately generated usable waveforms to capture the ordered ECG. There are known limitations with the bedside ECG (ex. there cannot be any dressings on the patient's chest that would prevent all electrodes from being placed in the appropriate location). We have also had issues with getting the bedside ECG to work on infants. This was a younger patient with no dressings so there should be no issue with the bedside cable. Patient did not sustain injury due to this event.
the device(s) may have
caused or contributed to:
Potential for patient harm
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