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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. FIXED IMAGING EQUIPMENT; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
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SIEMENS MEDICAL SOLUTIONS USA, INC. FIXED IMAGING EQUIPMENT; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED Back to Search Results
Device Problem Defective Device (2588)
Patient Problem No Code Available (3191)
Event Date 07/02/2019
Event Type  malfunction  
Event Description
Siemens imaging system error identified prior to placing patient on table for procedure.Engineering determined that siemens representative needed to diagnose and troubleshoot computer hardware problem.Patient moved back to holding area with plan to wait and see if it gets fixed and reschedule otherwise.Lack of alternative hybrid room availability likely means that we cannot accept ruptured aneurysms.This is second time this has happened to one of my patients within the last 3 weeks (last patient was anesthetized when the issue was identified), and therefore should be viewed as a pattern rather than an isolated event.
 
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Brand Name
FIXED IMAGING EQUIPMENT
Type of Device
SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
Manufacturer (Section D)
SIEMENS MEDICAL SOLUTIONS USA, INC.
40 liberty boulevard
mailcode: 65-1a
malvern PA 19355
MDR Report Key9798446
MDR Text Key182352728
Report Number9798446
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/09/2019,12/06/2019
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 Operator No Information
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/09/2019
Date Report to Manufacturer03/06/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age22265 DA
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