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

Model Number Z6MS TRANSDUCER

Device Problems Overheating of Device (1437); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/26/2017

Event Type  malfunction  

Manufacturer Narrative

This issue is under investigation.A follow-up report will be submitted when the investigation results are available.

Event Description

It was reported that the system displayed a usacquisitionhw_31 error message, an indication that the transducer is overheating.The reported phenomenon occurred during a 3d transesophageal echocardiography (tee) study.Since the system exhibited the error message sporadically, the user was able to complete the tee with the same transducer.There was no loss of data so the study was not repeated.The study was prolonged only by ten minutes but there was no patient or user injury reported.No additional information was provided.

Manufacturer Narrative

The device referenced in this report was returned to siemens for evaluation.During visual inspection, there was no physical damage noted on the articulation sleeve area.The device was functionally tested and the temperature monitoring error (usacquisitionhw_31 error) was able to be reproduced.During destructive analysis, it was found an open micro crack on the gastro flex # 7.The possible root cause of the reported phenomenon was caused by electrical trace micro crack due to insufficient reliability.A review of the device history record (dhr) was performed and there is no information to indicate any non-conformance at the time of manufacturing process.(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: 6317517
• MDR Text Key: 67153043
• Report Number: 3009498591-2017-00065
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142628
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2017
• 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?: No
• Date Manufacturer Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2016
• 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