MAUDE Adverse Event Report: SAMSUNG MEDISON CO., LTD. H60 DIAGNOSTIC ULTRASOUND SYSTEM; DIAGNOSTIC ULTRASOUND SYSTEM AND ACCESSORIES

Model Number	H60
Medical Device Problem Code	Incorrect Software Programming Calculations (1495)
Health Effect - Clinical Code	Pregnancy (3193)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Edd by lmp, percentile information, gestational age, and growth graph calculated by the fetal biometry measurement are displayed correctly even though the edd (aua) value is changed during exam review.Software version v2.01.05 has resolved the edd value issue and will prevent recurrence on all systems that has this version.No harm to the patient as a result of this issue.Revised software version v2.01.05 has been deployed.
Event or Problem Description
The edd (aua) value was normally displayed on the day of measurements, but in the exam review after the day of measurements, the existing edd (aua) value was changed.These intermittent changes in edd may indicate a potential fetal growth issue.

• Brand Name: H60 DIAGNOSTIC ULTRASOUND SYSTEM
• Common Device Name: DIAGNOSTIC ULTRASOUND SYSTEM AND ACCESSORIES
• Manufacturer (Section D): SAMSUNG MEDISON CO., LTD.; 3366, hanseo-ro, nam-myeon; hongcheon-gun gangweondo 250-8 74; KS 250-874
• MDR Report Key: 6337372
• Report Number: 3004938766-2017-00002
• Device Sequence Number: 11018325
• Product Code: IYN
• UDI-Device Identifier: 08806167752965
• UDI-Public: 08806167752965
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/16/2017
• Report Date (Section F): 02/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: H60
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/16/2017
• Device Age: 2 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 02/14/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 02/16/2017