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

Model Number	10762470
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Siemens conducted an analysis of the reported concerns and determined no system malfunction or failure.For stability reasons the described system behavior is normal as during an ortho study the manual movements in longitudinal and transverse directions are blocked.However, according to current knowledge, system movement in vertical direction is not blocked.The unit is working according to design and specifications.Internal id # (b)(4).
Event or Problem Description
A user of the ysio max unit shared with siemens their concerns that in the unlikely event that a patient falls during an ortho examination, hospital personnel would not be able to move the 3d stand out of the way quickly enough as the system cannot be unlocked for manual movement in longitudinal or transverse direction while performing ortho studies at the wall bucky.There is no patient involvement reported in this case.No injuries are attributed to this event.

• Brand Name: YSIO MAX
• Common Device Name: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; erlangen 91052 ; GM 91052
• MDR Report Key: 10302476
• Report Number: 3002808157-2020-37795
• Device Sequence Number: 16788412
• Product Code: KPR
• UDI-Device Identifier: 04056869004273
• UDI-Public: 04056869004273
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K181279
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2020

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 07/21/2020
• 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