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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 Use of Device Problem (1670)
Patient Problems Injury (2348); Patient Problem/Medical Problem (2688)
Event Date 09/02/2015
Event Type  malfunction  
Manufacturer Narrative
It is assumed that the incident occurred due to an operator error. Siemens requested additional information and photos to proceed with investigation. (b)(6).
 
Event Description
Siemens became aware of an incident on the ysio x-ray system in the (b)(6). A female patient came to the facility for an x-ray examination of her wrist. The patient was placed in a seated position at the end of the table of the ysio unit with her legs underneath the table and her hand and wrist on the tabletop. The operator accidentally initiated table movement by pressing "table down" switch simultaneously pushing the break release foot switch. The intention of the operator was to only release the breaks in roder to adjust the floating table top. The table top started to move down onto the patient's legs pressing on her right leg. The operator was able to stop the system movement and release the patient. The patient reported muscle damage as a result of the incident and seek medical attention due to pain and struggle to walk. The extent of the injury is unknown.
 
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Brand NameYSIO
Type of DeviceSTATIONARY X-RAY SYSTEM
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
henkestrasse 127
erlangen, 91052
GM 91052
Manufacturer (Section G)
SIEMENS HEALTHCARE GMBH
henkestrasse 127
erlangen, 91052
GM 91052
Manufacturer Contact
anastasia sokolova
40 liberty blvd, mc 65-1a
malvern, PA 19355
6104486478
MDR Report Key8545366
MDR Text Key143587979
Report Number3004977335-2015-04830
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 09/04/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10281013
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/18/2018
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/24/2019 Patient Sequence Number: 1
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