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 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation is on-going.A supplemental report will be submitted if additional information becomes available.Internal id (b)(4).

Event Description

Siemens was informed by its service organization that the ysio unit moved without given command by the operator.No information about patient involvement was provided to siemens.The reported incident occurred in (b)(6).

Manufacturer Narrative

The motor controller with system version vb10 was identified as the cause of the issue.A faulty motor controller may cause incorrect system positioning.Incorrect system positioning is not permanent; it is sporadic and lasts short period of time.However, when a movement command is triggered and an incorrect value of the motor controller is present, the movement is not executed for the actual positioning of the ceiling stand but based on the incorrect position value.Depending on the deviation between the real position and the incorrect position, the ceiling stand can move away from the operator after the movement command was triggered.It will drive over a stop position specified by the system and into the mechanic end stop.Siemens has prepared a software solution to detect incorrect position value of the ceiling stand.This software will help avoid incorrect system movement resulting from this error.This software will be rolled out for all affected systems with the field update instruction xp045/19/s.Concerned customer sites will be informed about the issue and the solution with an field safety notice distributed via a field update instruction xp044/19/s.The software solution detects the error state of the motor controller as well as incorrect movement of the system is prevented.After a system reboot of about 2-3 minutes the system becomes fully operational again.The realization of the measures is planned for january 2020.

• 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: 8901370
• MDR Text Key: 154567208
• Report Number: 3002808157-2019-93531
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2019
• 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: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other