MAUDE Adverse Event Report: GE VINGMED ULTRASOUND AS VIVID S70N V203; DIAGNOSTIC IMAGING ULTRASOUND

Lot Number 210315S70N

Device Problem No Visual Prompts/Feedback (4021)

Patient Problem Insufficient Information (4580)

Event Date 04/18/2022

Event Type  malfunction  

Manufacturer Narrative

Patient information could not be obtained due to country privacy laws.Udi: (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: hcs (b)(4).Ge healthcare's investigation is on-going at this time.

Event Description

The customer reported that a patient developed tamponade and acute loss of blood pressure, and emergency treatment is required when this occurs.They tried to use ultrasound, presumably as a guide for needle insertion to drain excess fluid (pericardiocentesis), and when doing so the vivid s70n diagnostic ultrasound system had become unresponsive (the screen was frozen).They forced a restart of the vivid s70n which took longer than expected.Meanwhile, the patient went into cardiac arrest.

Manufacturer Narrative

Gehcâs investigation has completed.Additional information was retrieved from the customer to determine the sequence of events and impact of the lockup upon patient care.The customer explained that a patientâs pressure dropped due to cardiac tamponade post-surgery.The customer needed to drain the pericardium immediately so the vivid s70 was selected for analysis & needle guidance.The vivid s70 was put into transportation mode & brought to the patient.However, when attempting to come out of transportation mode the vivid s70 locked up.The vivid s70 had to be forced off & then turned back on, and it took approximately 5-7 minutes to get the system running normally again.During this time the patient went into cardiac arrest and the doctor did not have time to wait for the ultrasound and did the drainage without the use of ultrasound.The vivid s70 was evaluated, and it was determined that the cause of the lockup when attempting to come out of transportation mode was due to either an intermittent firmware/software failure and/or mis-aligned communication cable between the power supply and controller.The gehc service engineer has re-seated the communication cable on the vivid s70 and the issue has not recurred.Additionally, the past three years of complaint file data was reviewed and the frequency of occurrence of a lockup coming out of transportation mode was determined to be rare.Thus, the risk associated with a temporary inability to use the system (a lockup) has been concluded to be acceptable and has been reduced afap.Lastly, a correction to the firmware issue was updated within forward production dec-2021.No further action is necessary at this time.

• Brand Name: VIVID S70N V203
• Type of Device: DIAGNOSTIC IMAGING ULTRASOUND
• Manufacturer (Section D): GE VINGMED ULTRASOUND AS; strandpromenaden 45; horten N-319 1; NO N-3191
• Manufacturer (Section G): GE VINGMED ULTRASOUND AS; strandpromenaden 45; horten N-319 1; NO N-3191
• Manufacturer Contact: joseph tamblyn ; 9900 w innovation dr; mail drop: rp-2130 / b4422; wauwatosa, WI 53226-4856
• MDR Report Key: 14654274
• MDR Text Key: 293958610
• Report Number: 9610482-2022-00001
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K182450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 210315S70N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2019
• 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