MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ARTIS Q.ZEN; SYSTEM, X-RAY

Model Number 10608967

Device Problem Defective Component (2292)

Patient Problem No Information (3190)

Event Date 01/29/2014

Event Type  malfunction  

Event Description

Siemens artis q.Zen x-ray tube failure.This is the third failure in two weeks of the x-ray tube.
=
manufacturer response for interventional x-ray imaging device, siemens artis q.Zen (per site reporter)
=
manufacturer continues to assist in resolving issues seen in their device.A potential root cause for the defective three x-ray tubes is being attributed to poor packaging during shipment.

• Brand Name: ARTIS Q.ZEN
• Type of Device: SYSTEM, X-RAY
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 51 valley stream pkwy; malvern PA 19355
• MDR Report Key: 4096104
• MDR Text Key: 4715140
• Report Number: 4096104
• Device Sequence Number: 1
• Product Code: IZI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 02/10/2014

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: Physician
• Device Model Number: 10608967
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/17/2014
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/17/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER DEVICES CONTRIBUTED IN THIS INCIDENT
• Patient Age: 71 YR