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U.S. Department of Health and Human Services

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

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G.E MEDICAL SYSTEMS ISRAEL LTD. VIVID I DIAGNOSTIC ULTRASOUND SYSTEM Back to Search Results
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).
 
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Brand NameVIVID I
Type of DeviceDIAGNOSTIC ULTRASOUND SYSTEM
Manufacturer (Section D)
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-b4422
wauwatosa, WI 
MDR Report Key9671392
MDR Text Key182120731
Report Number9615849-2020-00001
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
PMA/PMN Number
K121062
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received02/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/10/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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