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

Model Number Z6MS TRANSDUCER

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/02/2017

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 after the patient was sedated, the patient underwent a heart exam.In the middle of the exam, the transducer generated a usacquisitionhw_0 error and subsequently locked up the ultrasound system.The user rebooted the ultrasound system and the functionality was restored.The transducer was removed and a new transducer was reinserted into the patient to continue and complete the exam.There was a delay of 10-15 minutes to replace the transducer.There was no loss of data and there was no patient adverse event reported.No additional information was provided.

Manufacturer Narrative

This supplemental report is being submitted to update the device available for evaluation; provide the date new information was received and the type of report; provide the type of reportable event, provide the type of follow-up, update the device evaluated my manufacturer, provide the device manufacturing date, and update the event problem and evaluation codes; and provide the device evaluation results.The z6ms transducer referenced in this report was returned to siemens for investigation.During visual inspection, no visible damage was found on the articulation sleeve area.System testing was executed and no system error was able to be reproduced.Additional functional tests were conducted and the transducer was confirmed to be performing to its specifications.Based on the results of the investigation, there was no trouble found as the root cause of the reported error could not be identified.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
• MDR Report Key: 7049467
• MDR Text Key: 93362415
• Report Number: 3009498591-2017-00491
• 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
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• 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
• Date Manufacturer Received: 02/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1