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

Model Number Z6MS TRANSDUCER

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2016

Event Type  malfunction  

Event Description

It was reported that during equipment testing and before the procedure started, the probe failed leakage current test due to a hole in the articulation material.There was no patient involvement.No additional information was provided.

Manufacturer Narrative

Original submission narrative: the device referenced in this report was returned to siemens for evaluation.The transducer was investigated and leakage test failed due to a hole on the articulation sleeve material.The pin hole was confirmed through hipot test.A destructive analysis was performed and found no shield braid cut or physical damage.When the transducer was connected to the system, a system error (usacquisitionhw_31) occurred.The most likely cause of the reported phenomenon is liquid infiltration into the articulation sleeve hole which can lead to system error.A review of the design history file (dhf) did not show any non-conformance issue during device manufacturing process.Follow-up narrative: this supplemental report is being submitted to update the device available for evaluation, update the follow-up type, update the device evaluated by manufacturer, update the event problem and evaluation codes, and provide the investigation results.During the investigation, the leakage test failed due to a hole in the articulation sleeve.This could lead to an intermittent system error.An articulation sleeve material inspection & rework process has been implemented since nov.2015.This defective transducer is prior to the corrective action.Note: the original emdr was submitted to the non-production environment.This report is to submit to the production environment.This emdr contains both the initial and fu#2 (fu#1 could not be located).

• Brand Name: ACUSON Z6MS ULTRASOUND TRANSDUCER
• Type of Device: ULTRASOUND TRANSDUCER
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; business area ultrasound; 22010 se 51st street; issaquah WA 98029
• MDR Report Key: 6312038
• MDR Text Key: 282962827
• Report Number: 3009498591-2016-00363
• 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,user f
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2016
• Date Manufacturer Received: 02/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2015
• 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