MAUDE Adverse Event Report: SIEMENS HEALTHCARE ARTIS ZEE; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 10094135

Device Problem Data Problem (3196)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2014

Event Type  malfunction  

Event Description

Siemens became aware of a situation that during a clinical procedure, the artis zee floor system failed.The system failed as such that the release of x-ray was possible, but no images were being displayed.The system could not be brought back into operation.Siemens is unaware of any negative impact to the patient or operator.

Manufacturer Narrative

An investigation of the reported event was conducted.Inspection of the device showed the pc in good condition and all parts correctly installed and connections secure.Additional testing showed a defective copra/aaq board.The board was replaced and the system brought back into specification and turned over to the customer.This event occurred in (b)(6).

• Brand Name: ARTIS ZEE
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE; 51 valley stream pkwy, d01; malvern PA 19355
• Manufacturer Contact: meredith adams ; 51 valley stream pkwy.; malvern, PA 19355 ; 6104483237
• MDR Report Key: 4778774
• MDR Text Key: 5859957
• Report Number: 2240869-2015-06963
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K090745
• 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: 05/11/2015

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: 10094135
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/11/2015
• Initial Date FDA Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2009
• 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