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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE VINGMED ULTRASOUND AS 6VT-D PROBE W/VIVID S70 TRANSESOPHAGEAL ULTRASOUND PROBE

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GE VINGMED ULTRASOUND AS 6VT-D PROBE W/VIVID S70 TRANSESOPHAGEAL ULTRASOUND PROBE Back to Search Results
Model Number KN100120/VIVID S70
Device Problems Use of Device Problem (1670); No Apparent Adverse Event (3189)
Patient Problems Dysphagia/ Odynophagia (1815); Injury (2348); Skin Inflammation (2443)
Event Date 01/17/2017
Event Type  Injury  
Manufacturer Narrative
Patient information could not be obtained due to country privacy laws. (b)(4). 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. A follow-up report will be submitted when the investigation is complete.
 
Event Description
Customer in (b)(6) reported an injury to the patient, significant dysphagia post intraoperative surgery for mitral-clip placement, due to the use of a 6vt-d te probe with a vivid s70. Subsequently the physician proceeded to use a ct scan + gastrofibroscopy in emergency to evaluate the patient. They diagnosed a severe inflammation of the basal part of the esophagus.
 
Manufacturer Narrative
Ge's investigation of the event has completed. The device did not malfunction and it is operating as designed.
 
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Brand Name6VT-D PROBE W/VIVID S70
Type of DeviceTRANSESOPHAGEAL ULTRASOUND PROBE
Manufacturer (Section D)
GE VINGMED ULTRASOUND AS
strandpromenaden 45
horten
NO
Manufacturer Contact
joseph tamblyn
9900 w. innovation dr.
mail drop: rp-2138
wauwatosa, WI 
MDR Report Key6371615
MDR Text Key68770498
Report Number9610482-2017-00003
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
PMA/PMN Number
K141093
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 03/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKN100120/VIVID S70
Other Device ID NumberSEE BLOCK H10
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/1970
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/02/2017 Patient Sequence Number: 1
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