MAUDE Adverse Event Report: SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY CIOS FUSION; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 10308192

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2017

Event Type  malfunction  

Manufacturer Narrative

Siemens is conducting a thorough investigation of the reported events.As this event is under investigation, a root cause has not yet been determined.A supplement report will be filed upon completion of the investigation.This event occurred in (b)(6).

Event Description

It was reported to siemens that a malfunction occurred while operating the cios fusion system.During a surgical procedure, the c-arm was moved in an angular and orbital motion causing the grid to fall off.We are unaware of any impact to the state of health of any patient or operator involved.

Manufacturer Narrative

Siemens has completed an investigation of the reported event.Investigation results show that the issue was caused by insufficient fixation of the fd (flat detector) cover.During continued use of the c-arm, the plastic from the fd (flat detector) cover became loose and the brass insert was not secured properly.Sterile drapes at the fd, orbital position of the c-arm(>45°) and the low orbital velocity can mitigate the probability of falling parts during use.Additionally, for pediatric cases, the fd grid is detached from the fd due to dose reduction.The fd (flat detector) cover was replaced and the system was returned to clinical operation.No further actions are to be taken as there is no negative awareness in regards to the quality and performance of the affected component.

• Brand Name: CIOS FUSION
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE, BUSINESS AREA ADVANCED THERAPY; siemensstrasse 1; forcheim, 91301 ; GM 91301
• Manufacturer (Section G): SIEMENS HEALTHCARE GMBH; siemensstrasse 1; forchheim, 91301 ; GM 91301
• Manufacturer Contact: meredith adams ; 40 liberty blvd.; 65-1a; malvern, PA 19355 ; 6104486461
• MDR Report Key: 6464385
• MDR Text Key: 72347578
• Report Number: 2240869-2017-74120
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K153244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10308192
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/13/2017
• 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