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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 Electrical /Electronic Property Problem (1198)
Patient Problem Electric Shock (2554)
Event Date 11/29/2021
Event Type  Injury  
Event Description
Siemens service engineer encountered an electrical shock while working within the generator cabinet of the ysio unit. The engineer was clearing a little amount of dust and possibly got too close to the inverter board, when he experienced an electrical shock. The engineer was examined following the incident with no health consequences found. According to the ecg and blood tests, no damage to the heart could be determined. The service engineer stated that he should have isolated power before cleaning. The reported incident occurred in the (b)(6).
 
Manufacturer Narrative
Electrical safety tests were performed on the concerned unit, and it was confirmed that the system was safe. There was no system malfunction. The event was caused by the service engineer not following basic rules for electrical safety. Service instructions contain warning to de-energize the system prior to servicing it. Even though there were no health consequences in this case, a serious injury or death could have been the outcome. Since no medical treatment was necessary, the fact that the engineer received a shock is classified as only a minor injury in this case. Internal id # (b)(6).
 
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Brand NameYSIO
Type of DeviceSTATIONARY X-RAY SYSTEM.
Manufacturer (Section D)
SIEMENS HEALTHCARE GMBH
siemenstrasse 1
forchheim, 91301
GM 91301
Manufacturer (Section G)
SIEMENS HEALTHCARE GMBH
siemenstrasse 1
forchheim, 91301
GM 91301
Manufacturer Contact
anastasia sokolova
40 liberty blvd.
mc 65-1a
malvern, PA 19355
6104486478
MDR Report Key13052259
MDR Text Key283826685
Report Number3004977335-2021-09105
Device Sequence Number1
Product Code KPR
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K081722
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2021
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
Date Manufacturer Received12/13/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/21/2021 Patient Sequence Number: 1
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