MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. STELLANT DUAL CT INJECTOR; CT INJECTION SYSTEM

Model Number	60726807
Medical Device Problem Code	Electrostatic Discharge (2149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Bayer service visited the site on november 9, 2024 and performed a system checkout, including an electrical safety test, and confirmed that the system was operating to specification.This information does not constitute an admission that the device, the company, or its employees caused or contributed to a reportable event.
Event or Problem Description
The customer reported the following: during preparation of the medrad® stellant ct injection system (serial number (b)(6)), the technologist felt a shock in her hand when she touched the equipment.As per hospital protocol, the employee was referred to the emergency department.No additional information was provided.

• Brand Name: STELLANT DUAL CT INJECTOR
• Common Device Name: CT INJECTION SYSTEM
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; one bayer drive; indianola PA 15051
• Manufacturer (Section G): BAYER MEDICAL CARE INC.; one bayer drive; indianola PA 15051
• Manufacturer Contact: diane eckert ; one bayer drive; indianola, PA 15051 ; 7249408677
• MDR Report Key: 20797721
• Report Number: 2520313-2024-00021
• Device Sequence Number: 12715014
• Product Code: DXT
• UDI-Device Identifier: 00616258008943
• UDI-Public: (01)00616258008943(11)170724
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K082905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 60726807
• Device Catalogue Number: SCT W/CERTEGRA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown