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

Model Number Z6MS TRANSDUCER

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: the complaint was investigated for the acqusition 31 error during exam using z6ms transducer. The transducer was returned, and an investigation was performed. Engineers were able to reproduce the 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).

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 the patient was sedated, the patient underwent a transesophageal echocardiography (tee) procedure. During the procedure, the physician was scanning the patients' heart when the transducer generated an over-temperature message. The physician completed and ended the tee without rebooting the ultrasound system and without replacing the transducer. There was no loss of data and there was no patient adverse event reported. No additional information was provided.

• 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: 7038070
• MDR Text Key: 284684658
• Report Number: 3009498591-2017-00490
• 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
• Report Date: 02/14/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• 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
• Event Location: No Information
• Date Manufacturer Received: 01/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No