MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ARCADIS ORBIC; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY

Model Number 10143407

Device Problem Connection Problem (2900)

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

Event Date 12/16/2014

Event Type  malfunction  

Event Description

During a posterior spinal fusion case, 3d spin w/siemens arcadis orbic would not start.An error popped up on the sys console stating no connectivity to the navigation sys.A stryker rep, who was present at the facility during the procedure, called siemens local engineer w/ the issue.The engineer informed the stryker rep that the connector needed replacement; however, the connectivity could be established either by taking the back panel off and connecting directly to the pc or by using a second network connection on the sys.After a 30 min delay in procedure to troubleshoot all navigation connections, the case was completed successfully.No add'l anesthesia was not needed.There are no injuries attributed to this event.

Manufacturer Narrative

Siemens local svc engineer was dispatched to the site.The engineer replaced cat6 connector.The unit is working according to specs.This report was submitted march 18, 2015.

• Brand Name: ARCADIS ORBIC
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 51 valley stream pkwy.; ms d-02; malvern PA 19355 140
• Manufacturer (Section G): SIEMENS AG; siemensstrasse1; forchheim 9130 1; GM 91301
• Manufacturer Contact: anastasia mason ; 51 valley stream pkwy.; malvern, PA 19355-1406
• MDR Report Key: 4632490
• MDR Text Key: 5613702
• Report Number: 2240869-2015-01091
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K042793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10143407
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/25/2014
• Initial Date FDA Received: 03/19/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other