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

Model Number 10281013

Device Problem Use of Device Problem (1670)

Patient Problems Injury (2348); Patient Problem/Medical Problem (2688)

Event Date 09/02/2015

Event Type  malfunction  

Manufacturer Narrative

It is assumed that the incident occurred due to an operator error.Siemens requested additional information and photos to proceed with investigation.(b)(6).

Event Description

Siemens became aware of an incident on the ysio x-ray system in the (b)(6).A female patient came to the facility for an x-ray examination of her wrist.The patient was placed in a seated position at the end of the table of the ysio unit with her legs underneath the table and her hand and wrist on the tabletop.The operator accidentally initiated table movement by pressing "table down" switch simultaneously pushing the break release foot switch.The intention of the operator was to only release the breaks in roder to adjust the floating table top.The table top started to move down onto the patient's legs pressing on her right leg.The operator was able to stop the system movement and release the patient.The patient reported muscle damage as a result of the incident and seek medical attention due to pain and struggle to walk.The extent of the injury is unknown.

Manufacturer Narrative

**resubmission of initial report as per fda on 4/3/19** the investigation showed that the incident was caused by an operator error.The patient was positioned in a danger zone, which is not allowed due to potential hazard when lowering patient table according to the operator manual xpb7-010.620.01.01.02.(page 31).The tabletop movement was released by user (accidentally) by pressing the 'table down' foot switch at the same time as pressing the break release foot switch (both on table base).The intention was to only release the brakes to adjust the floating table top.According to the hospital administration the patient was examined and an x-ray of the affected area was taken and no injury could be determined.The patient complained of pain, however, no medical intervention was needed.Siemens is not aware of any similar cases when both foot switches were pressed at the same time by mistake.

• Brand Name: YSIO
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• MDR Report Key: 8545366
• MDR Text Key: 143587979
• Report Number: 3004977335-2015-04830
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 10281013
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other