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

Model Number	10762470
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	10/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Siemens became aware of an incident that occurred on the (b)(6) max unit.A patient went in for examination and was sitting in a chair next to the patient table.While the technician was adjusting the height of the patient table, it moved down onto the patients leg.The technician then quickly pressed the emergency button to release the patient.It was reported that patient legs were pinched, and this resulted in the distal thigh of the patient being swollen.The reported incident occurred in (b)(6).
Additional Manufacturer Narrative
The operator manual contains a warning not to position a patient with legs under the table and not to move the table while patient is in seated position near the table.The patient tabletop is equipped with a collision detection system that stops system movement in case a collision is detected.Only the table frame has no collision detection.The investigation is on-going.A supplemental report will be submitted if additional information becomes available.Internal id # (b)(6).
Additional Manufacturer Narrative
The issue was investigated in detail.According to the information received, the patient table had been lowered onto the patient's leg resulting in swelling of the distal thigh.It was confirmed that no medical intervention was necessary.The log files were delayed and no longer contained the time of event as the log files were overwritten.As the log files covering the time of event were no longer available for investigation, thus, the system configuration could also not be examined.There is a warning in the operator manual (doc.Id: xpb7-030.620.01.01.02; register 2 "system safety"; page 38-39) not to position patient legs under the table and not to move the table while a patient is seated near the table.The patient tabletop (not the table frame) is equipped with a collision detection system that stops system movements in case a collision is detected.The table frame itself, per system specifications, is not equipped with a collision sensor.According to the provided information the customer confirmed that the issue was caused by operator.No system malfunction could be determined.

• Brand Name: YSIO MAX
• Common Device Name: STATIONARY 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 Key: 12703869
• Report Number: 3004977335-2021-02110
• Device Sequence Number: 1559016
• Product Code: KPR
• UDI-Device Identifier: 04056869004273
• UDI-Public: 04056869004273
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K181279
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2021

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
• Operator of Device: Health Professional
• Device Model Number: 10762470
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2021
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 03/31/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown