MAUDE Adverse Event Report: BAYER MEDICAL CARE INC. STELLANT FLEX; INJECTOR, CONTRAST MEDIUM, AUTOMATIC

Model Number 85631829

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Insufficient Information (4580)

Event Date 03/24/2021

Event Type  malfunction  

Event Description

Received call indicating contrast injector had error and stopped working.Comments from call where, "giving a critical error says contact service, did try to shut down." manufacturer response for contrast injector, stellant flex (per site reporter).Mfg sent our fse and installed replacement injector head.

• Brand Name: STELLANT FLEX
• Type of Device: INJECTOR, CONTRAST MEDIUM, AUTOMATIC
• Manufacturer (Section D): BAYER MEDICAL CARE INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 12391660
• MDR Text Key: 268975253
• Report Number: 12391660
• Device Sequence Number: 1
• Product Code: IZQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 85631829
• Device Catalogue Number: FLEX
• 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: 08/11/2021
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1