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

Model Number 10762470

Device Problem Unintended Collision (1429)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2021

Event Type  Injury  

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 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
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; siemenstrasse 1; forchheim, 91301 ; GM 91301
• MDR Report Key: 12413435
• MDR Text Key: 269530185
• Report Number: 3004977335-2021-94766
• Device Sequence Number: 1
• Product Code: KPR
• UDI-Device Identifier: 04056869004273
• UDI-Public: 04056869004273
• Combination Product (y/n): N
• PMA/PMN Number: K181279
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10762470
• Date Manufacturer Received: 08/26/2021
• 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): Other