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 Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 10/19/2017

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 when the transducer was connected to the ultrasound system, it generated usacquisitionhw_31 error (overtemp) 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

This supplemental report is being submitted to provide additional event information, provide and update the initial reporter information, update the report source, provide the date the new information was received, and update/correct the patient code.

Event Description

Additional information was received and it was reported that during equipment testing, the reported usacquisitionhw_31 error (overtemp) was generated when the transducer was connected to the ultrasound system.The patient was already sedated at this time and was being prepared by the physician to undergo a transesophageal echocardiography (tee) procedure.The transducer was replaced with a different but similar device to continue and complete the tee along with the same ultrasound system.There was no loss of data and there was no patient adverse event reported.No additional information was provided.

Manufacturer Narrative

Investigation: the complaint was investigated for an acquisition 31 error with a z6ms transducer.The transducer was returned, and an investigation was performed.Engineers were able to reproduce an acquisition 31 error.The cause of the issue was determined to be a gastro flex thermistor reliability issue; 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 at the site by service.(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: 7033424
• MDR Text Key: 93107133
• Report Number: 3009498591-2017-00468
• 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,health
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2017
• 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: 02/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1