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 Problem No Information (3190)

Event Date 08/25/2017

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 transducer was plugged into the ultrasound system, it prompted an overheating issue.The reported issue occurred while the transducer was inside the patient.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

The device referenced in this report could not be tracked down for investigation because the serial number could not be identified; therefore, the investigation of the device could not be performed and the cause of the reported phenomenon could not be determined.A probable cause of the reported phenomenon was determined to be gastro flex durability that can cause the over temperature (acquisition hardware) errors.Reference complaint # (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: 6858441
• MDR Text Key: 85792391
• Report Number: 3009498591-2017-00368
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• 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?: No
• Date Manufacturer Received: 04/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1