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

Model Number 10281013

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Electric Shock (2554)

Event Date 07/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The ysio unit was checked by siemens local service.Siemens engineer did not find any system malfunction.Siemens product specialist visited the concerned site as well to perform safety measurements.No system issues could be identified.The investigation is on-going.A supplemental report will be submitted if additional information becomes available.This report was submitted august 9, 2017.Customer's address: (b)(6).

Event Description

It was reported that an operator received an electrical shock from the detector on the ysio system.The operator collapsed and was taken to intensive care unit at the facility.The operator was released several hours later.The reported incident occurred in germany.

Manufacturer Narrative

The issue was investigated in detail.The initial investigation was performed at customer site by the siemens service organization, specialists from xp r&d department and the independent siemens testing laboratory (eh&s).No indication for a system failure was found that pointed to the ysio system as a cause for this event.Also no indication for a contribution of the ysio system to the reported event was found during the on-site investigations.All performed tests did not show any failure or malfunction of the system.During the disassembly of potentially affected components from the customer system no failure or defect was detected.The disassembly was carried out by the siemens service organization and factory installation personnel.Further investigation and tests of these components were performed at the test lab of the manufacturer but were concluded without any indication for defect or malfunction.Hypotheses regarding possible causes of the event were developed and assessed.None of them did provide any indication that the cause of the event was linked to the ysio system.Since no malfunctions could be found the investigation was continued at an independent external testing institute (sgs - institute fresenius).The investigation results did not provide any hint for a contribution of the system to the event.Despite extensive investigation of this event the root cause could not be determined.All potentially affected components were replaced at the customer system and the system was tested before it was released for regular hospital operation.No reoccurrence or similar system behavior is known since the system was released again for regular hospital operation in (b)(6) 2017.This report was submitted january 31, 2018.

• Brand Name: YSIO
• Type of Device: STATIONARY 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; 6104486478
• MDR Report Key: 6777544
• MDR Text Key: 82174174
• Report Number: 3002808157-2017-03871
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K081722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10281013
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 07/17/2017
• Initial Date Manufacturer Received: 07/17/2017
• Initial Date FDA Received: 08/09/2017
• Supplement Dates Manufacturer Received: 01/30/2018
• Supplement Dates FDA Received: 01/31/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening