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

Model Number 10281013

Device Problem Component Falling (1105)

Patient Problem Injury (2348)

Event Date 08/24/2015

Event Type  malfunction  

Manufacturer Narrative

The exam room and the system were checked by siemens local service.According to the engineer, the fixing screws under the ceiling construction were loose.It is assumed that this issue is related to room preparation the installation instruction axb7-021.812.01.23.02, pages 22-26 and maintenance instruction xpb7-020.831.20.03.01, pages 69-72 contain detailed information on correct ceiling construction fixation.The customer was informed not to use the system until the issue is resolved.The transverse rail was dismounted by siemens local service.A team of technical experts visited the facility to conduct an investigation and secure the ceiling construction.The reported issue is under investigation and a supplemental report will be submitted if additional information becomes available.This report was submitted september 17, 2015.

Event Description

Siemens became aware of a transverse rail dropping down from the longitudinal rail on the ceiling while a physician was performing a procedure on the ysio system.The transverse rail fell down and hit the physician resulting in a small scratch.No medical intervention was needed for the physician.No patient injuries are attributed to the event.The reported event occurred in (b)(6).

Manufacturer Narrative

The investigation showed that the sub-construction was performed not according to the planning guide.Due to improper shimming and little contact areas the entire sub-construction was quite flexible, which led to the carriage wagon to slip out of the rail.The sub-construction is not a component of the ysio system.Therefore, no components of the ysio system were identified as a root cause for the derailing.A customer safety advisory notice was distributed to the customers in china via an update instruction xp055/15/s to inform about a potentially weak substructure fixation of the ceiling rail system and potential risk of the traverse to drop down.Siemens also released an update instruction xp054/15/s to prevent repetition of the failure by installing a safety clamp for the ceiling rail system.The under-ceiling construction is unique for healthcare facilities in china and the two update instructions were rolled out only in china.The modification was performed on future installed base to avoid any potential risks due to an incorrect sub-construction.According to the received information the reported issue at the concerned customer site has been repaired.This report was submitted august 17, 2016.

• Brand Name: YSIO
• Type of Device: STATIONARY X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS GMBH; henkesstrasee 127; erlangen, 91052 ; GM 91052
• Manufacturer (Section G): SIEMENS GMBH; henkesstrasse 127; erlangen 91052 ; GM 91052
• Manufacturer Contact: anastasia sokolova ; 40 liberty blvd, mc 65-1a; malvern, PA 19355 ; 6104486478
• MDR Report Key: 5084016
• MDR Text Key: 26491216
• Report Number: 2240869-2015-04611
• Device Sequence Number: 1
• Product Code: KPR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K081722
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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