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U.S. Department of Health and Human Services

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

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GE VINGMED ULTRASOUND AS 6VT-D PROBE TRANSESOPHAGEAL ULTRASOUND PROBE Back to Search Results
Model Number KN100110
Device Problems Failure to Disinfect (1175); Microbial Contamination of Device (2303)
Patient Problem Bacterial Infection (1735)
Event Type  Injury  
Manufacturer Narrative
Patient information could not be obtained due to country privacy laws. Ge has finished it's investigation of this issue with the customer. It was agreed that the customer had not properly followed instructions for cleaning and disinfecting the probe. The proper instructions for cleaning and disinfection of the probe were reviewed with the customer. The contaminated probes were removed from use immediately when the issue was found by the customer. With new probes and proper cleaning and disinfection it has been confirmed there were no more patient infections observed. The initial reporter is located outside the u. S. , and therefore this information is not provided due to country privacy laws.
 
Event Description
Customer reported to (b)(6) authorities an issue with te probes causing several patient contaminations with e. Coli and pseudomonas microbes. The (b)(6) authorities in turn notified ge.
 
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Brand Name6VT-D PROBE
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 Key6225566
MDR Text Key63957745
Report Number9610482-2017-00001
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
PMA/PMN Number
K131514
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial
Report Date 01/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKN100110
Device Lot Number203319
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/19/2014
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: 01/05/2017 Patient Sequence Number: 1
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