MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON Z6MS ULTRASOUND TRANSDUCER; ULTRASOUND DEVICE

Model Number Z6MS TRANSDUCER

Device Problem Signal Artifact/Noise (1036)

Patient Problems No Consequences Or Impact To Patient (2199); Sedation (2368)

Event Date 07/17/2017

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

It was reported that after given light anesthesia, the patient underwent a 2d and 4d transesophageal echocardiography (tee) procedure.During patient scanning in b-mode when the color dopler was activated, the user observed colored artifact on the image.The user rebooted the ultrasound system but did not remove the transducer.When the artifact disappeared, the user continued and completed the tee.There was a 10-minute delay in completing the procedure.There was no patient adverse event reported.No additional information was provided.

Manufacturer Narrative

Investigation: the complaint was investigated for color artifact in z6ms images.The transducer was returned, and an investigation was performed.It was found that the cause of the image artifacts on the transducer was coaxial cable manufacturing issue, which is being addressed through a capa.This transducer was manufactured prior to the corrective action.(b)(4).

• Brand Name: ACUSON Z6MS ULTRASOUND TRANSDUCER
• Type of Device: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view CA 94043 4050
• MDR Report Key: 6879580
• MDR Text Key: 87880659
• Report Number: 3009498591-2017-00389
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K142628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: Z6MS TRANSDUCER
• Device Catalogue Number: 10436113
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1