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

Model Number Z6MS TRANSDUCER

Device Problem Device Displays Incorrect Message (2591)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 08/04/2017

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 the transducer prompted a usacquisitionhw_40 error when it was plugged in to the ultrasound system.No additional information was provided.Multiple attempts were made via email to obtain additional information regarding the reported phenomenon but with no results.

Manufacturer Narrative

This supplemental report is being submitted to provide additional event description, update health professional and occupation of initial reporter, provide the date received by manufacturer, and correct the patient code.

Event Description

Additional information was received and it was reported that the event occurred during patient planning and equipment testing and prior to the transducer probe being inserted into the patient.The transducer was replaced to continue and complete the transesophageal echocardiography (tee) procedure.The tee was delayed by 10-15 minutes while the replacement transducer was obtained.There was no loss of data and there was no patient adverse event reported.No additional information was provided.

Manufacturer Narrative

Investigation: the complaint was investigated for the z6ms transducer displaying an acquisition 40 error message.The transducer was returned, and an investigation was performed.The system error was reproduced.No gastroflex short was found, but the distal flex and mmx could not be analyzed because of tiga epoxy inside tip.No issues were found with the mpm board and spc board.An intermittent electrical short at the cable level was found during multimeter tests, which could affect image problem or system error.The cause of the short on the transducer was a manufacturing issue with the coaxial cables.The cable assembly manufacturer changed the their manufacturing process through a capa.This transducer was manufactured before the capa.Complaint reference #: (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: 6807642
• MDR Text Key: 83158411
• Report Number: 3009498591-2017-00344
• 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: Biomedical Engineer
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2016
• 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