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 09/28/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: the complaint was investigated for a temperature problem the the z6ms probe. The transducer was returned, and an investigation was performed. Engineers were able to reproduce an aquisition 31 error. The cause was determined to be articulation sleeve reliability issue. A c-flex articulation sleeve material inspection & rework process was implemented since novevmber 2015. And a new sleeve material change was implemented since septebmer 2016. This transducer was prior to the corrective action. The transducer was replaced at the site. (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 while the patient was in the middle of undergoing a transesophageal echocardiography (tee) procedure, a temperature issue occurred soon after the transducer was connected to the ultrasound system. The physician rebooted the ultrasound system and the functionality was restored. The tee was continued and subsequently completed without replacing the transducer. The delay was only when the system was rebooted. 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: 6937273
• MDR Text Key: 283390431
• Report Number: 3009498591-2017-00437
• 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: 01/30/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/10/2017
• 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: 01/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No