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

Model Number Z6MS TRANSDUCER

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2017

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.(b)(4).

Event Description

It was reported that after the patient was sedated, the patient underwent an aortic valve replacement (avr) procedure.In the middle of the procedure while the physician was taking the patients' images, the transducer caused the ultrasound system to shut down.The ultrasound system was rebooted; however, the user utilized a different but similar ultrasound system and another transducer to complete the procedure.There was a delay of 30-45 minutes due to equipment changes.The 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 a z6ms transducer failing leakage test.The transducer was returned, and an investigation was performed.The investigation found a hole and contaminant inside the articulation sleeve, and a tip bite mark.Facory leakage testing passed; however, the hi-pot testing failed.A physical hole was also confirmed.The cause of the issue was determined to be contaminant inside the the articulation sleeve through the physical hole, caused by customer mishandling.It is recommended that the customers carefully handle the transducers.(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: 7087489
• MDR Text Key: 94869348
• Report Number: 3009498591-2017-00505
• 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: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1