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

Model Number 10281013

Device Problem Use of Device Problem (1670)

Patient Problem Pain (1994)

Event Date 04/21/2019

Event Type  Injury  

Manufacturer Narrative

The user was instructed that handle bar on the bucky wall stand is meant for different purposes and this is outlined in the operator manual.Internal complaint id (b)(4).

Event Description

It was reported that a patient lost balance during an exam on the ysio unit.During a foot acquisition the patient lost balance and grabbed the hand bar on the bucky wall stand, which is not designed for this purpose.It is used only to position patients during thorax acquisitions when patient is in a "stretched" position.As a result the patient pulled the bar out causing him to fall backwards.The patient complained of some pain in his hip and was sent to the er for further testing.There was no injury detected and no treatment was needed.

• Brand Name: YSIO
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; henkestrasse 127; erlangen, 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd, mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 8597642
• MDR Text Key: 144664876
• Report Number: 3002808157-2019-79904
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10281013
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other