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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Nausea (1970)

Event Date 07/09/2016

Event Type  malfunction  

Event Description

Received a call from cath lab staff and spoke with dr who stated an urgent patient with nstemi was undergoing pci when they noted images were not crossing and did not appear to be saved during the case.The patient had to be transported to another room and received additional contrast and studies repeated.Cts on call had already been notified by staff.Dr shared his concern that this is the second time this has happened to him and that this is unacceptable when we are trying to ensure we perform critical procedures rapidly to ensure guideline based care of our patients.He asked that i come in to follow up on this which i have done.I also notified the cardiac application analyst because this may involve software.Upon my arrival, the patient had already been taken to csicu; she was receiving additional iv fluids to ensure adequate hydration since additional contrast had to be given to complete the study.There appears to be a hard drive failure.One has been ordered to ship by 10 am tomorrow.A siemens engineer will be here with him to install.There may be a way to recover the images - would require working with engineers in (b)(4).He asked that i send him the patient information in an email so he may troubleshoot the image recovery with siemens.I have sent that information by email and i have given him my cell phone number to notify me if there are any issues with the installation tomorrow.I have spoken with csicu staff and asked if the patient was aware of the equipment issue and the nurse indicated she was.The patient is stable for now and because she is very nauseous i did not speak with her.I will follow up and asked the nurse to contact me if the patient's labs indicated any complications from the additional contrast.

• Brand Name: ARTIS ZEE
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 40 liberty blvd; mailcode 65-1a; malvern PA 19355
• MDR Report Key: 5986640
• MDR Text Key: 55908259
• Report Number: 5986640
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/09/2016

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
• Other Device ID Number: 282696
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2016
• Event Location: Hospital
• Date Report to Manufacturer: 09/09/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO