MAUDE Adverse Event Report: GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI) 3SC-RS PROBE W/VIVID IQ; ULTRASOUND IMAGING SYSTEM

Device Problems Electromagnetic Interference (1194); Poor Quality Image (1408)

Patient Problems Death (1802); Thrombosis (2100)

Event Type  Death  

Manufacturer Narrative

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.

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: 3SC-RS PROBE W/VIVID IQ
• Type of Device: ULTRASOUND IMAGING SYSTEM
• Manufacturer (Section D): GE MEDICAL SYSTEMS (CHINA) CO., LTD (WUXI); no. 19 changjiang road; national hi-tech dev. zone; wuxi 21402 8; CH 214028
• MDR Report Key: 9765688
• MDR Text Key: 181238196
• Report Number: 9710602-2020-00071
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• PMA/PMN Number: K161706
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death