MAUDE Adverse Event Report: SIEMENS AG AXIOM ARTIS ZEEGP; SYSTEM, XRAY, ANGIOGRAPHIC

Model Number 10280959

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 11/15/2013

Event Type  malfunction  

Event Description

Siemens became aware of a sporadic failure where the system goes into intermittent bypass fluoro.We are unaware of any injury to the patient or operator.

Manufacturer Narrative

This report is being filed with the fda on (b)(4) 2014.Initial assessment of the issue on (b)(4) 2013 was deemed a non-reportable event.Following the completion of a full investigation of results and root cause analysis on (b)(4) 2014, this event is now considered to be a reportable event as the potential exists for system malfunction and delay of procedure.To date, no information regarding patient injury or injury to system operators has been reported.This event occurred in (b)(6).

• Brand Name: AXIOM ARTIS ZEEGP
• Type of Device: SYSTEM, XRAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS AG; siemensstrasse 1; forcheim 9130 1; GM 91301
• Manufacturer (Section G): SIEMENS AG; siemensstrasse 1; forcheim 9130 1; GM 91301
• Manufacturer Contact: meredith adams ; 51 valley stream parkway; malvern, PA 19355 ; 6104483237
• MDR Report Key: 3931749
• MDR Text Key: 4575187
• Report Number: 2240869-2014-11765
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/21/2014

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: 10280959
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/28/2014
• Initial Date FDA Received: 04/15/2014
• 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
• Patient Sequence Number: 1