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); Application Program Freezes, Becomes Nonfunctional (4031)

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

Event Date 02/16/2017

Event Type  malfunction  

Manufacturer Narrative

Original submission 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.Follow-up narrative: this supplemental report is being submitted to update the device available for evaluation, provide the date received by manufacturer, update device evaluated by manufacturer, provide the device manufacture date, update the event problem and evaluation codes, and provide the device investigational results.The device referenced in this report was returned to siemens for evaluation.During visual inspection, a bite mark was noted at the distal tip.A system investigation was conducted and the reported system hardware error was able to be reproduced.Factory leakage test passed at full level.During destructive analysis, it was found a vcw and vnxb net short.No cable and gastro flex #3 shorts were confirmed.The possible cause of the reported complaint is electrical short in the transducer tip area.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.The original emdr was submitted to the non-production environment.This report is to submit to the production environment.All original files are attached.This emdr contains both the initial and fu#1.

Event Description

It was reported that the patient was already sedated and intubated with the probe and undergoing a transesophageal echocardiography (tee) examination.In the middle of the procedure, the transducer prompted a usacquisitionhw error message.The user rebooted the system in an attempt to complete the tee; however, the system froze so the exam was completed on another ultrasound system.The exam was prolonged by 30 minutes while the replacement system was obtained.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.; business area ultrasound; 22010 se 51st street; issaquah WA 98029
• Manufacturer Contact: khalil thomas ; business area ultrasound; 22010 se 51st street; issaquah, WA 98029 ; 4253929180
• MDR Report Key: 6560070
• MDR Text Key: 274930861
• Report Number: 3009498591-2017-00100
• 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: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• 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?: Yes
• Date Manufacturer Received: 05/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2016
• 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