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

Device Problems Naturally Worn (2988); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 10/05/2020

Event Type  malfunction  

Event Description

The collimator stopped rotating and the motor controllers were being burnt out.Numerous cables rubbing inside the c-arm during 3d acquisitions.Tech support engineer that we are working with now took the pictures and will be sending the original x3 cable back to (b)(4) for investigation.

• 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: 10733054
• MDR Text Key: 213003019
• Report Number: 10733054
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/16/2020
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1