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

Model Number	10762470
Medical Device Problem Code	Unintended Collision (1429)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the information provided by siemens local service, the patient was seated under the tabletop and the collision was detected by the system.Collision detection stopped the system movement.It was stated by the service technician that when the collision and table bottom limit occur at the same time, the table lift does not work immediately following the collision.However, it takes about one second to regain table movement.This was shown in the provided video.The operator manual contains a warning not to position a patient with legs under the table and to not move the table while patient is seated near the table.Internal id # (b)(4).
Event or Problem Description
Siemens became aware of an incident that occurred on the ysio max system.During patient examination the radiographer moved that table top down, trapping a child's leg between the table top and the chair.It was stated that it was not possible to move the tabletop upward immediately but only after about one second delay.Except for some redness observed on the child's leg, there were no injuries reported in this case.The incident occurred in the (b)(6).

• Brand Name: YSIO MAX
• Common Device Name: STATIONARY X-RAY SYSTEM
• MDR Report Key: 12413435
• Report Number: 3004977335-2021-94766
• Device Sequence Number: 17059232
• Product Code: KPR
• UDI-Device Identifier: 04056869004273
• UDI-Public: 04056869004273
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K181279
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/02/2021

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 09/02/2021
• 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
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other