MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC AXIOM ARTIS DBC; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 7728392

Device Problem Positioning Problem (3009)

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

Event Date 07/24/2017

Event Type  malfunction  

Event Description

Patient was moved to electrophysiology (ep) lab, sedated and placed under general anesthesia a foley catheter was placed.After patient was prepped and draped, the x-ray equipment would not move into position.The unit was re-booted several times without a successful restart.The procedure was cancelled and patient was taken off the table and moved to the post-anesthesia care unit (pacu) for recovery and discharge.Biomedical engineering was made aware, and they attempted to reset unit.Unit worked without problem on prior case in that room.There was no evidence of malfunction predicted prior to procedure start.

• Brand Name: AXIOM ARTIS DBC
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC; robert phillips; 40 liberty boulevard mailcode: 65-1a; malvern PA 19355
• MDR Report Key: 6958235
• MDR Text Key: 89616266
• Report Number: 6958235
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2017

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: Physician
• Device Model Number: 7728392
• Other Device ID Number: 127762
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2017
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/19/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 30 YR