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

Model Number ARTIS ICONO

Device Problems Computer Software Problem (1112); No Display/Image (1183); Failure to Read Input Signal (1581)

Patient Problem Hemorrhagic Stroke (4417)

Event Date 01/16/2021

Event Type  malfunction  

Event Description

Siemens icono bi-plane angio-suite had major software malfunction during start of acute stroke treatment.Physician unable to review prior dsa runs to evaluate vessels.Physician unable to view imaging of dyna ct acquire to determine if hemorrhage has occurred or not to determine next course of treatment.Tech unable to view/film/adjust any images/exposure factors in control room (control room system completely locked).These factors directly affected patient care throughout the case.Unable to view prior images required physician to view/ memorize imaging.Ct data would have shown md a bleed which would have changed md course of action.

• Brand Name: ARTIS ICONO
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS HEALTHCARE GMBH; 40 liberty boulevard; mailcode: 64-1a; malvern PA 19355
• MDR Report Key: 11378640
• MDR Text Key: 233497419
• Report Number: 11378640
• Device Sequence Number: 1
• Product Code: IZI
• 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: 01/27/2021

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: ARTIS ICONO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/27/2021
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/25/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 31390 DA
• Patient Weight: 103