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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
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SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM; SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC Back to Search Results
Model Number 11148775
Device Problem Operating System Becomes Nonfunctional (2996)
Patient Problem Insufficient Information (4580)
Event Date 02/08/2022
Event Type  malfunction  
Event Description
The touchscreen of the acuson sequoia ultrasound system froze during an exam, and health care provider was unable to use the machine until a manual restart was completed.This incident caused a delay in patient care.
 
Event Description
The touchscreen of the acuson sequoia ultrasound system froze during an exam, and health care provider was unable to use the machine until a manual restart was completed.This incident caused a delay in patient care.
 
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Brand Name
ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM
Type of Device
SYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS USA, INC.
22010 south east 51st street
mailcode: 64-1a
issaquah WA 98029 7002
MDR Report Key13782108
MDR Text Key287254741
Report Number13782108
Device Sequence Number1
Product Code IYN
UDI-Device Identifier04056869173566
UDI-Public(01)04056869173566
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 03/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number11148775
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/01/2022
Date Report to Manufacturer03/16/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/16/2022
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/16/2023
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age28835 DA
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