MAUDE Adverse Event Report: G.E MEDICAL SYSTEMS ISRAEL LTD. VIVID I BT10*020473V; ULTRASOUND SYSTEM, IMAGING, CARDIAC

Device Problem Flare or Flash (2942)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2020

Event Type  malfunction  

Manufacturer Narrative

Device manufactured in 2009.Therefore, no udi.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Gehc's investigation is ongoing at this time.Legal manufacturer: (b)(4).

Event Description

The vivid-i cart power cord had smoke and small fire which required no intervention to resolve.The power cable was immediately removed from the mains socket and the flame extinguished by itself.There was no patient involved, and no injury or other damage reported.Gehc visually inspected the power cord and found a visible break of shielding between strain relief and the plug that connects to the cart.

Manufacturer Narrative

Gehc's investigation has completed.The power cable was damaged at the strain relief, and visual inspection determined there was a crack in the outer sheath & shielding, and no burn marks nor heat damage, such as melting, to the cable were evident.It is concluded that the most probable cause of cable damage was due to wear and tear over the years (system was manufactured in 2009).Additionally, the customer continued to use the cable knowing there was damage to it.Gehc evaluated complaint trends and determined there are no trends of this issue.Risk was evaluated and it has been concluded that current mitigations are in place to maintain the risk level at afap.The damaged power cable was replaced, and no further actions are required at this time.

• Type of Device: ULTRASOUND SYSTEM, IMAGING, CARDIAC
• Manufacturer (Section D): G.E MEDICAL SYSTEMS ISRAEL LTD.; nativ ha'or street no. 1; haifa 35085 10; IS 3508510
• MDR Report Key: 11243184
• MDR Text Key: 229098153
• Report Number: 9615849-2021-00002
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• PMA/PMN Number: K092140
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• 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: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1