MAUDE Adverse Event Report: SIEMENS AG/SIEMENS HEALTHCARE GMBH PROCEDURAL TABLE AXIOM ARTIS Q; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 400-173419

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 03/14/2022

Event Type  malfunction  

Event Description

Unable to initiate x-ray imaging on siemens peripheral lab procedural table.Fda safety report id # (b)(4).

• Brand Name: PROCEDURAL TABLE AXIOM ARTIS Q
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS AG/SIEMENS HEALTHCARE GMBH
• MDR Report Key: 13810745
• MDR Text Key: 287576150
• Report Number: MW5108286
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/16/2022

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: 400-173419
• Device Catalogue Number: 400-173419
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White