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U.S. Department of Health and Human Services

MAUDE Adverse Event Report:; ULTRASOUND IMAGING SYSTEM
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; ULTRASOUND IMAGING SYSTEM Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
This report is resubmitted on request by the fda to correct initial report.
 
Event Description
Previously submitted.
 
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Type of Device
ULTRASOUND IMAGING SYSTEM
MDR Report Key7318814
MDR Text Key199701885
Report Number3009498591-2016-00026
Device Sequence Number1
Product Code IYN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Patient Sequence Number1
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