Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: G.E MEDICAL SYSTEMS ISRAEL LTD. VIVID S6; DIAGNOSTIC ULTRASOUND SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

G.E MEDICAL SYSTEMS ISRAEL LTD. VIVID S6; DIAGNOSTIC ULTRASOUND SYSTEM Back to Search Results
Model Number R2418529-6
Device Problem Smoking (1585)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
No patient involved.The initial reporter is located outside the u.S., and therefore this information is not provided due to country privacy laws.Legal manufacturer: (b)(4).
 
Event Description
A customer reported that a vivid s6 diagnostic ultrasound system was receiving charging for the battery in a dedicated room and the clinician wanted to use the system in another room so it was unplugged and moved while in standby mode to another location.Suddenly white smoke come out of it and the vivid s6 was moved to a corridor.The customer used a fire extinguisher to put out the device fire.
 
Manufacturer Narrative
Gehc's investigation has completed.The failed battery was retrieved and analyzed by the battery manufacturer.The battery manufacturer concluded the most probable root cause is failure within the lithium ion cell which caused the battery to fail and led to thermal runaway.Additionally, this is a rare case of cell defect that occurs once out of ~1.5 million cells.There is no process nor design root cause as this is a component failure.The device was replaced to correct the issue.No further action is planned at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VIVID S6
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 Key11159334
MDR Text Key226517451
Report Number9615849-2021-00001
Device Sequence Number1
Product Code IYN
Combination Product (y/n)N
PMA/PMN Number
K121063
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 03/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberR2418529-6
Device Lot Number4315VS6
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-