MAUDE Adverse Event Report: SIEMENS HEALTHCARE GMBH ARTIS Q FLOOR; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 10848280

Device Problem Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2022

Event Type  malfunction  

Event Description

Siemens system will not transfer xray images to pacs system.

• Brand Name: ARTIS Q FLOOR
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 40 liberty boulevard; mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 14117758
• MDR Text Key: 289336323
• Report Number: 14117758
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 04056869009971
• UDI-Public: (01)04056869009971
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/03/2022

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: 10848280
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/15/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32485 DA
• Patient Sex: Male