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); Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2017

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.

Event Description

It was reported that a patient was put under sedation to undergo a heart exam. Although the exact timeline of the failure was not reported, there was an indication that the exam was in progress when the transducer prompted a temperature error. The error occurred when the transducer was connected to the ultrasound system. The doctor removed the transducer from the patient and reinserted a new transducer to continue and successfully complete the exam. It is unknown whether the ultrasound system was rebooted. There was a delay of approximately 15 minutes while the new transducer was prepared. 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 having a temp 31 error message. The transducer was returned, and an investigation was performed. The system error was reproduced during the investigation. The cause of the issue was determined to be a gastro flex thermistor reliabiility issue; this is related to design. The improvements to the gastro flex trace were implemented into forward production, since july 2017. The returned transducer was manufactured prior to the corrective action. The transducer was replaced at the site by service. (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: 6878949
• Report Number: 3009498591-2017-00385
• 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
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• 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
• Event Location: No Information
• Date Manufacturer Received: 01/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No