MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON SEQUOIA C526 ULTRASOUND SYSTEM; ULTRASOUND DEVICE

Model Number ACUSON SEQUOIA C256

Device Problem Compatibility Problem (2960)

Patient Problem Insufficient Information (4580)

Event Date 12/28/2016

Event Type  malfunction  

Manufacturer Narrative

This issue is under investigation.A follow-up report will be submitted when the investigation results are available.Follow-up narrative: this supplemental report is being submitted to update the device available for evaluation, update the follow-up type, update the device evaluated by manufacturer, update the event problem and evaluation codes, and provide the investigation results.Investigation: the complaint was reported for the system no longer recognizing the acunav swiftlink cable adapter during an ice procedure.As per the complaint submitter, the swiftlink was damaged by the customer.So a new one was purchased from a 3rd party source.No further service calls were placed by the customer since the replacement.The defective swiftlink adapter was not sent back to siemens for investigation; therefore, a root cause could not be determined.

Event Description

It was reported that the ultrasound system did not recognize the acunav swiftlink cable adapter during an intracardiac echocardiography (ice) procedure.The user terminated the procedure and rescheduled the patient for a rescan at later date until a replacement device could be obtained.There was no patient or user injury reported when the event occurred.At this writing, there is no confirmed report whether the patient had been rescanned.No additional information was provided.

• Brand Name: ACUSON SEQUOIA C526 ULTRASOUND SYSTEM
• 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: 6483586
• MDR Text Key: 280691822
• Report Number: 3009498591-2017-00014
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063085
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACUSON SEQUOIA C256
• Device Catalogue Number: 8246951
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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