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

Model Number Z6MS TRANSDUCER

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 12/07/2017

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.Reference: (b)(4).

Event Description

It was reported that the transducer generated a usacquisitionhw_35 error message.No additional information was provided.Multiple attempts were made via email to obtain additional information regarding the reported phenomenon and patient outcome but with no results.

Manufacturer Narrative

Investigation: the complaint was investigated for a z6ms transducer displaying an acquisition 35.The transducer was returned, and an investigation was performed.Engineers were not able to reproduce the acquisition 35 error, but found an acquisition 40 error.The cause of the error message was due to the reliability of the articulation sleeve material.A new sleeve material change was implemented in september 2016.This transducer was manufactured prior to the corrective action.The transducer from this complaint was replaced at the site.Complaint reference #: (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
• Manufacturer Contact: scott christiansen ; 685 east middlefield road; mountain view, CA 94043-4050 ; 4252709862
• MDR Report Key: 7151384
• MDR Text Key: 96238995
• Report Number: 3009498591-2017-00544
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K142628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 03/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2016
• 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