MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. MEDRAD® MARK 7 ARTERION INJECTION SYSTEM; BAYER MEDICAL CARE INC.

Device Problems Fire (1245); Sparking (2595)

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

Event Date 07/20/2022

Event Type  malfunction  

Event Description

The medrad mark 7 aterian contrast injector began to spark and briefly caught fire at the electrical cord before one of the tech¿s in the room unplugged the unit.

• Brand Name: MEDRAD® MARK 7 ARTERION INJECTION SYSTEM
• Type of Device: BAYER MEDICAL CARE INC.
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 15191583
• MDR Text Key: 297521262
• Report Number: 15191583
• Device Sequence Number: 1
• Product Code: DXT
• 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: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 07/25/2022
• Event Location: Other
• Date Report to Manufacturer: 08/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1