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

Model Number Z6MS TRANSDUCER

Device Problems Device Displays Incorrect Message (2591); Temperature Problem (3022)

Patient Problem No Patient Involvement (2645)

Event Date 08/25/2017

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 the transducer prompted an over-temperature error when it was connected to the ultrasound system.This occurred prior to a planned transesophageal echocardiography (tee) procedure.The patient was not yet in the room at the time the event occurred; therefore, there was no patient involvement.No additional information was provided.

Manufacturer Narrative

Not applicable, no adverse event.Lot # and expiration date not applicable.Not applicable, not an implant.Investigation: the complaint was investigated for the z6ms transducer showing an overtemperature error when first connected.The transducer was returned, and an investigation was performed.The error message was reproduced during the investigation.The cause of the issue was determined to be a gastro flex thermistor trace fault, caused by insufficient gastro flex reliability; this is related to design.Improvements to the gastro flex trace were implemented into forward production, since july 2017.The transducer returned from the customer site was manufactured prior to the corrective action.The transducer was replaced on site by service.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 ; 4255571625
• MDR Report Key: 6838461
• MDR Text Key: 84995672
• Report Number: 3009498591-2017-00366
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/16/2018

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
• 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
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 09/01/2017
• Supplement Dates Manufacturer Received: 12/26/2017
• Supplement Dates FDA Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2016
• 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