MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON 18L6 HD LINEAR ARRAY ULTRASOUND TRANSDUCER; ULTRASOUND DEVICE

Model Number 18L6 HD TRANSDUCER

Device Problems Improper Device Output (2953); Output Problem (3005)

Patient Problem No Information (3190)

Event Date 04/03/2017

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to siemens for evaluation.If additional information is received or if the device is returned at a later date, this report will be supplemented.

Event Description

During a review for safety, it was found that the 18l6 hd transducer displayed a positive image artifact in the near-field of the image.The transducer probe was replaced and the reported phenomenon was resolved.No additional information was provided.Multiple attempts were made via email to obtain additional information regarding the reported phenomenon but with no results.

Manufacturer Narrative

This supplemental report is being submitted to update the device available for evaluation (see section d10); provide the date new information was received by manufaturer (see section g4); provide the type of report (see section g7); provide the type of reportable event (see section h1); provide the type of follow-up (see section h2); update the device evaluated by manufacturer (see section h3); provide the device manufacture date (see section h4); update the event problem and evaluation codes (see section h6); and provide the device evaluation results (see section h10).The device referenced in this report was returned to siemens for evaluation.Visual inspection of the device showed the coax cable was kinked next to the strain relief.During system test, the investigator found a recognition error and not image artifact.The recognition error occurred due to the damaged coax cable.The possible root cause of the coax cable damage is likely do the ptfe tape.The tape was moved back from s/r and this caused friction with the shield when bending the coax cable.Relevant operators were retrained for cabling and rework.A review of the device history record (dhr) was performed and there is no information to indicate any non-conformance at the time of manufacturing process.Reference complaint # (b)(4).

Event Description

Additional information was received and it was reported that the patient was supine on the bed undergoing an unspecified ultrasound study when the 18l6hd transducer displayed a positive image artifact in the near-field of the image.The intended study was completed with the same system and transducer.The study was not repeated because there was no loss of data.There was no patient adverse event reported.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to provide additional event information (see section b5), correct the patient code.(see section h6) and the date received by manufacturer (see section 4).This report is being submitted retrospectively per fda request.

• Brand Name: ACUSON 18L6 HD LINEAR ARRAY ULTRASOUND TRANSDUCER
• Type of Device: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view CA 94043 4050
• Manufacturer Contact: jim dabbs ; 22010 se 51st st; issaquah, WA 94043-4050 ; 4255571625
• MDR Report Key: 6456733
• MDR Text Key: 71739066
• Report Number: 3009498591-2017-00136
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K142876
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 18L6 HD TRANSDUCER
• Device Catalogue Number: 10789400
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1