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U.S. Department of Health and Human Services

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

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SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON SEQUOIA C526 ULTRASOUND SYSTEM ULTRASOUND DEVICE Back to Search Results
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.
 
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Brand NameACUSON SEQUOIA C526 ULTRASOUND SYSTEM
Type of DeviceULTRASOUND DEVICE
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS USA, INC.
business area ultrasound
22010 se 51st street
issaquah WA 98029
MDR Report Key6483586
MDR Text Key280691822
Report Number3009498591-2017-00014
Device Sequence Number1
Product Code IYO
Combination Product (y/n)N
PMA/PMN Number
K063085
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial
Report Date 08/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberACUSON SEQUOIA C256
Device Catalogue Number8246951
Device Lot NumberN/A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/28/2016
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

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