Patient information could not be obtained due to country privacy laws.The initial reporter did not provide the date of incident.Vivid iq udi: (b)(4).The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Ge healthcare's investigation is ongoing.Legal manufacturer: parallel design sas (hcs nice) - (b)(4).Device evaluation anticipated, but not yet begun.
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A customer reported that a 3sc-rs ultrasound probe, when used with a vivid iq, had interference when activating the color doppler and pw doppler.This occurred while attempting to perform a bedside echocardiographic exam at a coronary icu when the interference appeared suddenly making it impossible to perform the exam.The patient had acute dysfunction due to thrombosis of a mitral mechanical prosthesis, which was undiagnosed due to the interference, who ended up dying for lack of diagnosis hours after the failed attempt to perform the exam.
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Gehcâs investigation has completed.The probe alleging to be defective and displaying poor image quality was returned to gehc for root cause analysis.Based upon test inspections of the probe (visual inspection, image quality inspection, electroacoustic inspection), no probe malfunction or other safety concern was identified.Additionally, the customer, who is physician, was questioned about the probeâs contribution to the patient death and she responded that the patient outcome would have been the same regardless of the probe performance, and that the probe did not cause nor contributed to the death of the patient.However, the image quality could hinder her diagnosis.It is therefore concluded that the root cause of the adverse event is not imputable to a probe failure.It is potentially because of the patient condition as well as circumstances around the exam.The customer was provided a replacement probe.At this time, gehc is not pursuing any further action in response to this adverse event.
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