MAUDE Adverse Event Report: G.E MEDICAL SYSTEMS ISRAEL LTD. VIVID I; DIAGNOSTIC ULTRASOUND SYSTEM

Device Problems Fire (1245); Smoking (1585); Sparking (2595); Battery Problem (2885)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 01/11/2020

Event Type  malfunction  

Manufacturer Narrative

No report of patient involvement.Udi: not applicable.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: (b)(4).Device evaluation anticipated, but not yet begun.

Event Description

A customer reported that a fire started from a battery-powered ultrasound device, the vivid i.They reported ignition, sparks and smoke from the rear/back of the vivid i.The fire was extinguished by a fire extinguisher (c02 initially and then sprayed water because it could not be extinguished).At the time of the event the vivid i was on a cart and was battery powered (no ac).

Manufacturer Narrative

Gehc's investigation has completed.The vivid-i battery was returned to gehc for in-depth analysis, and the investigation concluded that the most probable root cause is related to failure in the lithium ion cell which caused the battery to fail and led to thermal runaway.This event occurs once out of ~1.5 million cells of this model that have been implemented in all ge products.Additionally, there is no process root cause.The damaged device was taken out of service.No further actions will be taken at this time.

• Brand Name: VIVID I
• Type of Device: DIAGNOSTIC ULTRASOUND SYSTEM
• Manufacturer (Section D): G.E MEDICAL SYSTEMS ISRAEL LTD.; nativ ha'or street no. 1; haifa 35085 10; IS 3508510
• MDR Report Key: 9671392
• MDR Text Key: 182120731
• Report Number: 9615849-2020-00001
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K121062
• 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: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1