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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GE VINGMED ULTRASOUND AS 6VT-D PROBE 6VT-D ULTRASOUND TRANSDUCER

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GE VINGMED ULTRASOUND AS 6VT-D PROBE 6VT-D ULTRASOUND TRANSDUCER Back to Search Results
Model Number H45581BJ
Device Problems Difficult to Insert (1316); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Injury (2348); Perforation of Esophagus (2399)
Event Date 12/20/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws. (b)(4). Ge healthcare's investigation is on-going at this time.
 
Event Description
A customer complained to ge healthcare that a patient's esophagus was pierced by the 6vt-d ultrasound probe during a te exam. The physician also noted probe insertion was difficult. Initial evaluation of the 6vt-d probe indicates the probe did not malfunction.
 
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Brand Name6VT-D PROBE
Type of Device6VT-D ULTRASOUND TRANSDUCER
Manufacturer (Section D)
GE VINGMED ULTRASOUND AS
strandpromenaden 45
horten N-319 1
NO N-3191
Manufacturer Contact
joseph tamblyn
9900 w. innovation dr.
mail drop: rp-2130/b4422
wauwatosa, WI 
MDR Report Key9578347
MDR Text Key174687367
Report Number9610482-2020-00001
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 03/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberH45581BJ
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/23/2019
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: 01/10/2020 Patient Sequence Number: 1
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