MAUDE Adverse Event Report: SEEH10 VENUE R2; DIAGNOSTIC ULTRASOUND SYSTEM

Lot Number VEB002237

Device Problems Use of Incorrect Control/Treatment Settings (1126); Display or Visual Feedback Problem (1184)

Patient Problems Death (1802); Insufficiency, Valvular (1926); Mitral Insufficiency (1963)

Event Date 07/27/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information could not be obtained due to country privacy laws.Legal manufacturer name is ge medical systems ultrasound & primary care diagnostics llc.(b)(4).The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Legal manufacturer: (b)(4).

Event Description

It was reported to gehc from a customer that a patient received a diagnostic ultrasound cardiac scan by experienced senior physicians using a venue on (b)(6) 2019, due to suspicion of a cardiac condition.The customer was scanning in color doppler using customer-defined imaging presets (as opposed to ge-default imaging presets which are optimized for cardiac imaging) and no color doppler signal corresponding to a cardiac condition was observed during the ultrasound examination on the venue.The patient was moved to another hospital where acute mitral valve insufficiency was detected.Patient passed away (b)(6) 2019.The customer is indicating there was a relevant therapy delay for the patient due to the venue not displaying the mitral valve insufficiency with color doppler.Gehcare's investigation is ongoing, and the investigation includes determining cause of death and the timeline of events.

Manufacturer Narrative

Ge's investigation included a review of exam images, logfiles, complaint history, the design file and an interview the customer.Patient images and system logfiles revealed that the user was utilizing imaging presets unlike factory-default imaging presets.These user defined presets utilized a color flow gain parameter 5db lower than the factory-default, and it was observed that the user did not adjust & optimize color flow gain parameters while scanning the patient.Ge was able to adjust the color flow gain parameters within the patient's exam image, and the patient's mitral valve regurgitation was observed.The customer was contacted for additional information about this case.The physician provided additional details including there was no death involved with the patient, and the death was inadvertently reported.For the patient exam of concern, the physician's perception is that there was a delay in therapy for the patient.The physician also confirmed he did not adjust color flow gain parameters during the exam, and that he was using user-defined imaging presets at the time.In conclusion, the device did not fail to meet its specifications and there is no evidence of any malfunction or issues with the system.Based upon the investigation ge believes the most probable cause of the delay in therapy due to the user being unable to visualize the patient's mitral valve regurgitation is from the user's failure to adjust the color flow gain parameter.The root cause is considered to be user error.This root cause does not impact the product's design, training, service or installation including the use of user-defined imaging presets.

• Brand Name: VENUE R2
• Type of Device: DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer (Section D): SEEH10; 9900 innovation drive; wauwatosa, WI 53226 4856
• Manufacturer Contact: joseph tamblyn ; 9900 innovation drive; mail drop rp-2130; wauwatosa, WI
• MDR Report Key: 8961088
• MDR Text Key: 156479613
• Report Number: 3005860720-2019-00002
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K180599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: VEB002237
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Death
• Patient Age: 48 YR
• Patient Sex: Male