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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
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SIEMENS; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED Back to Search Results
Device Problems Component Falling (1105); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 01/28/2016
Event Type  malfunction  
Event Description
Recent history of monitor suspension arm (boom) failure at another hospital in ca.Supported monitors and suspension arm were found on the floor at that hospital but no personnel or patients were present at the time.Corporate identified that the same equipment exists at several other hospitals, including this one.They requested that a medsun report be entered, reportedly from an inadequate response by the vendor.It was also reported that neither siemens or mavig will be inspecting this equipment.Manufacturer response for suspension arm (boom), (brand not provided) (per site reporter): notified by hospital system corporate personnel - neither siemens or mavig will be inspecting this equipment.
 
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Type of Device
SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
Manufacturer (Section D)
SIEMENS
40 liberty boulevard
mailcode: 65-1a
malvern PA 19355
MDR Report Key5515921
MDR Text Key40875409
Report Number5515921
Device Sequence Number1
Product Code JAA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 02/11/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/11/2016
Event Location Hospital
Date Report to Manufacturer02/11/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/22/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
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