MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ARTIS VD 11C; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Device Problems Device Alarm System (1012); Visual Prompts will not Clear (2281)

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

Event Date 12/13/2019

Event Type  malfunction  

Event Description

At 09:11 hours, ipp9 sent an error message to the monitors of: "limited table/stand movement".The table and ap flat detector moved significantly slow like it was in collision mode.All of the resets were complete with troubleshooting the room and the error did not clear.At this time, clinical imaging was in the core and witnessed with issue.A hard shut down and reboot of the room was then completed.The error still didn't clear, and the physician could not proceed with the procedure in ipp9.The intubated patient was then moved to another room for completion of the procedure.A service call was placed to siemen's and the service clinician came to assess the room.Manufacturer response for system, x-ray, fluoroscopic, image-intensified, (artis vd 11c) (per site reporter).The rep from siemens has not arrived yet.

• Brand Name: ARTIS VD 11C
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 40 liberty boulevard mailcode: 64-1a; malvern PA 19355
• MDR Report Key: 9676042
• MDR Text Key: 177966526
• Report Number: 9676042
• Device Sequence Number: 1
• Product Code: JAA
• 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: 12/16/2019

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
• 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: 12/16/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28105 DA