MAUDE Adverse Event Report: GE VINGMED ULTRASOUND AS VIVID S70N; PULSED DOPPLER ULTRASOUND IMAGINGSYS

Model Number VIVID S70 V204

Device Problem Failure to Power Up (1476)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2022

Event Type  malfunction  

Event Description

The customer has reported that the vivid s70n diagnostic ultrasound system did not boot up, after having put the system in transportation mode, so that it could be used for an emergency cardiac case/patient.Gehc obtained additional information from the customer and more specifically the physician could not utilize the vivid s70n to guide and control how the cannulas for the extracorporeal membrane oxygenation (ecmo) device are placed into blood vessels during a time-critical intervention, and other ultrasound systems were unavailable at that time.Because the vivid s70n would not immediately boot up the physician attempted installation of the emco cannulas w/o ultrasound guidance and emco installation was unsuccessful for reasons not specified by the customer.The patient died 45 minutes after the intervention.Additionally, the customer reported the vivid s70n took more than 15 minutes to boot up.Gehc's investigation is ongoing.

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 haifa u/s - nativ ha'or street no.1 israel haifa 3508510.Gehc's investigation is ongoing.

Manufacturer Narrative

B1: additional information was collected from the customer where they stated, â the use of (the vivid s70n) degraded care,â and, â the patient was in a precarious state at the start, and the occurrence of death is multifactorial (anesthesia, resuscitation, etc.).Â쳌 therefore, both adverse event and product problem check boxes are selected.B3, incident date: additional information received from the customer stated that the event occurred on 01-dec-2022 and not on 06-dec-2022 as initially notified to ge healthcare (gehc).Therefore, gehc is updating the date of the event in this form to 01-dec-2022.Gehc's investigation has completed.The investigation identified internally generated electromagnetic noise on the system communication bus (i2c) could intermittently prevent the ultrasound scanner from booting up, and this is likely the cause of the device malfunction.Furthermore, the investigation concluded that the patient's severe underlying medical status was the main contributor to the patient outcome.Gehc has initiated a capa to further assess improvements to the electromagnetic compatibility (emc) of the communication bus.

• Brand Name: VIVID S70N
• Type of Device: PULSED DOPPLER ULTRASOUND IMAGINGSYS
• Manufacturer (Section D): GE VINGMED ULTRASOUND AS; strandpromenaden 45; horten N-319 1; NO N-3191
• Manufacturer (Section G): G.E MEDICAL SYSTEMS ISRAEL LTD.; nativ ha'or street no. 1; haifa 35085 10; IS 3508510
• Manufacturer Contact: joseph tamblyn ; 9900 w innovation dr; mail drop: rp-2130 / b4422; wauwatosa, WI 53226-4856
• MDR Report Key: 16108056
• MDR Text Key: 307687084
• Report Number: 9615849-2023-00001
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K211216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VIVID S70 V204
• Device Lot Number: 111162S70N
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2021
• 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