MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number SIREMOBIL COMPACT L

Device Problems Electrical /Electronic Property Problem (1198); Smoking (1585); Temperature Problem (3022)

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

Event Date 07/27/2022

Event Type  malfunction  

Event Description

Siemens c-arm head end unit began to smoke during surgery case per staff.Unit was removed from operating room and wheeled outside of building.After inspection it was revealed that the computer inside of the unit had a hard drive connector that got hot and began to smoke.Fda safety report id# (b)(4).

• Brand Name: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Type of Device: MAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.
• MDR Report Key: 15138133
• MDR Text Key: 297100527
• Report Number: MW5111190
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/27/2022

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: SIREMOBIL COMPACT L
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1