MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON X700 ULTRASOUND SYSTEM; ULTRASOUND DEVICE

Model Number ACUSON X700

Device Problem Measurement System Incompatibility (2982)

Patient Problem Insufficient Information (4580)

Event Date 02/02/2016

Event Type  malfunction  

Manufacturer Narrative

Original submission narrative: this issue is under investigation.A follow-up report will be submitted when the investigation results are available.Follow-up #1 narrative: additional information was received and it was reported that during a cardiac procedure, the physician recognized the inconsistent measurement result with the 4v1c after installing the system.The physician completed the procedure using the p8-3 transducer from an x300 ultrasound system.There was no patient or user injury reported.No additional information was provided.This supplemental report is being submitted to provide additional event information, and to provide the date new information was received.Describe event or problem: as a result of a recent fda inspection, we are retrospectively reviewing complaints and associated documents for compliance to the regulations from 2015 to date.We have strengthened our mdr reporting criteria and we are reporting the attached medical device report as a follow-up to the original mdr submitted 10/04/2016.Follow-up #2 narrative: this supplemental report is being submitted to provide the date new information was received and provide the type of report; provide the type of reportable event and provide the type of follow-up; and provide additional manufacturer narrative.The investigation results showed that the scanning conditions from the complaint were not the same for both transducers.Based on our internal investigation, there was no meaningful difference in measurement results between the 4v1c and p8-4 transducers when the scanning conditions were the same.Reference complaint (b)(4).

Event Description

As a result of a recent fda inspection, we are retrospectively reviewing complaints and associated documents for compliance to the regulations from 2015 to date.We have strengthened our mdr reporting criteria and we are reporting the attached medical device report in accordance with our new criteria.As a result of this retrospective review, this mdr is being reported immediately upon discovery.It was reported that the customer has been complaining about the inconsistent cardiac measurement results when using the p8-4 and 4v1c transducer in cw doppler mode to scan the same patient in the same exam position.Siemens replaced and installed a new system at the user facility in a different department.We are in the process of collecting patient outcome information, but due to our commitment to the fda, we are filing upon discovery of a potential adverse event and without patient outcome information.Should we receive further information in regards to this report, we will file a follow-up report.

Event Description

As a result of a recent fda inspection, we are retrospectively reviewing complaints and associated documents for compliance to the regulations from 2015 to date.We have strengthened our mdr reporting criteria and we are reporting the attached medical device report as a follow-up to the original mdr submitted 10/04/16.Additional information was received and it was reported that during a cardiac procedure, the physician recognized the inconsistent measurement result with the 4v1c after installing the system.The physician completed the procedure using the p8-3 transducer from an x300 ultrasound system.There was no patient or user injury reported.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to provide additional event information, and to provide the date new information was received.

Manufacturer Narrative

This supplemental report is being submitted to provide the date new information was received and provide the type of report (see sections g4,g7); provide the type of reportable event and provide the type of follow-up (see sections h1.H2); and provide additional manufacturer narrative (see section h10).The investigation results showed that the scanning conditions from the complaint were not the same for both transducers.Based on our internal investigation, there was no meaningful difference in measurement results between the 4v1c and p8-4 transducers when the scanning conditions were the same.Reference complaint # (b)(4).

• Brand Name: ACUSON X700 ULTRASOUND SYSTEM
• Type of Device: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; business area ultrasound; 22010 se 51st street; issaquah WA 98029
• Manufacturer Contact: khalil thomas ; business area ultrasound; 22010 se 51st street; issaquah, WA 98029 ; 4253929180
• MDR Report Key: 7930524
• MDR Text Key: 281203313
• Report Number: 3009498591-2016-00361
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: VM
• PMA/PMN Number: K141846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACUSON X700
• Device Catalogue Number: 10658844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1