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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH YSIO STATIONARY X-RAY SYSTEM

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SIEMENS HEALTHCARE GMBH YSIO STATIONARY X-RAY SYSTEM Back to Search Results
Model Number 10281013
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Bone Fracture(s) (1870); Complaint, Ill-Defined (2331)
Event Date 06/04/2016
Event Type  Injury  
Manufacturer Narrative
A supplemental report will be submitted if additional information becomes available. This report was submitted august 25, 2016. (b)(6).
 
Event Description
On august 3, 2016 siemens became aware of an incident that occurred earlier this year on the ysio system. Patient was hospitalized due to strong chest pains caused by a fall. The patient was in no condition to perform an x-ray exam in standing position and remained in supine position on stretchers. During positioning of the x-ray stand, the tube moved downwards and hit patient's thorax. It is unclear whether the downwards movement was unintended system movement (following the position of the detector) or it was caused by an operator error. The operator stopped all system movements after he realized that the tube moved downwards. Following this incident the patient's thorax, sternum and ribs were x-rayed. According to the received information the patient left the hospital against doctor's advice and returned 14 days later with a broken sternum. It was recently reported that the injury was caused by the patient's earlier fall on the heating element. The reported event occurred in (b)(6).
 
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Brand NameYSIO
Type of DeviceSTATIONARY X-RAY SYSTEM
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
henkesstrasse 127
erlangen, 91301
GM 91301
Manufacturer (Section G)
SIEMENS HEALTHCARE GMBH
henkesstrasse 127
erlangen, 91052
GM 91052
Manufacturer Contact
anastasia sokolova
40 liberty blvd, mc 65-1a
malvern, PA 19355
6104486478
MDR Report Key5903457
MDR Text Key52983567
Report Number2240869-2016-04532
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K081722
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10281013
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/25/2016 Patient Sequence Number: 1
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