MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS ARTIS ZEE; C-ARM

Model Number 10094135

Device Problem Break (1069)

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

Event Date 03/22/2016

Event Type  malfunction  

Event Description

A (b)(6) female with history of lymphoma of breast with metastasis with abnormal ekg and shortness of breath.During the diagnostic cardiac catheterization.The siemens x-ray equipment malfunctioned.The sensor was not working and the table would not move side to side.The pt was transferred from the table and moved to a different cath lab room and completed without difficulty.Siemens was notified, equipment was placed out of service.Siemens responded the same day, based on their assessment, parts were ordered for repairs and were changed with a potentiometer part # (b)(4) and the proximity switch part # (b)(4).

• Brand Name: ARTIS ZEE
• Type of Device: C-ARM
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS; 51 valley stream parkway; malvern PA 19355
• MDR Report Key: 5628327
• MDR Text Key: 44336723
• Report Number: MW5062038
• Device Sequence Number: 1
• Product Code: JAA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/19/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2016
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 33