MAUDE Adverse Event Report: SIEMENS HEALTHCARE ARTIS ZEE BIPLANE; SYSTEM, XRAY, ANGIOGRAPHIC

Model Number 10094141

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 09/12/2014

Event Type  malfunction  

Event Description

It was reported to siemens that during a difficult emergency brain procedure, the table malfunctioned.The customer stated that this resulted in a critical situation as the table was not able to be moved anymore.This customer did not report any impact to the health and safety of the patient and siemens is unaware of any health consequence to the patient.

Manufacturer Narrative

During investigation it was determined that the issue was limited to the x-ray table, although x-ray was still possible at the time of event.Table components were replaced and full functionality was available.The system was turned over to the hospital for continued patient use.Additionally, the materials exchanged are still undergoing an investigation and root cause has not yet been determined.A supplement report will be filed at the conclusion of the investigation.This event occurred in (b)(6).This report is being filed with the fda october 15,2014.

• Brand Name: ARTIS ZEE BIPLANE
• Type of Device: SYSTEM, XRAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE; 51 valley stream parkway; d02; malvern PA 19355
• Manufacturer (Section G): SIEMENS HEALTHCARE
• Manufacturer Contact: meredith adams ; 51 valley stream parkway; d02; malvern, PA 19355 ; 6104483237
• MDR Report Key: 4269319
• MDR Text Key: 5028737
• Report Number: 2240869-2014-07485
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K073290
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 09/15/2014

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: 10094141
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/15/2014
• Initial Date FDA Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1