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

Model Number 10281013

Device Problems Use of Device Problem (1670); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation is on-going.A supplemental report will be submitted if additional information becomes available.

Event Description

Siemens was informed of unintended system movement of the ysio unit.The x-ray tube was not in the locked position and it jerked back hitting a wheelchair.There was no person on the wheelchair.There are no injuries attributed to this event.

Manufacturer Narrative

The described issue was examined.No malfunction or failure of the system was identified.The analysis of the logfiles did not indicate any unintentional or unusual movement.There were two events in which a motorized movement of the affected axis was active around the indicated time of the incident.For both movements the dead man grip (dmg) was activated by the user.Motorized movement is only triggered if the two signals (dmg and motion request) are applied to the motor controller at the same time.Thus, both movements were initiated intentionally by the operator.The log files also show an operation of the organ program (ogp) drive function.This function automatically moves the system to a defined starting position, according to the selected ogp.This may have been interpreted as an unintended movement by the operator.During investigation it was identified that the 3d force sensor was defective.However, this part is not relevant for the described issue.The force sensor was replaced on site by local service.

• Brand Name: YSIO
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkesstrasse 127; erlangen, 91301 ; GM 91301
• MDR Report Key: 8514016
• MDR Text Key: 141926003
• Report Number: 3002808157-2019-76261
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• PMA/PMN Number: K081722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10281013
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other