MAUDE Adverse Event Report: BAYER MEDICAL CARE INC MEDRAD PRESSURE INJECTOR; INJECTOR, CONTRAST MEDIUM, AUTOMATIC

Device Problems Retraction Problem (1536); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2019

Event Type  malfunction  

Event Description

Medrad injector stopped in the middle of injection, tech restarted injector and it happened again after already undocking the syringe and redocking it.Injected again and injector and control pad completely shut off.Only 52cc out of 100cc of contrast was given to patient because of repeated malfunction.It is noted that the syringe on docking a does not retract automatically when a syringe is taken off.

• Brand Name: MEDRAD PRESSURE INJECTOR
• Type of Device: INJECTOR, CONTRAST MEDIUM, AUTOMATIC
• Manufacturer (Section D): BAYER MEDICAL CARE INC; 1 bayer drive; indianola PA 15051
• MDR Report Key: 9117593
• MDR Text Key: 160030316
• Report Number: 9117593
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/23/2019
• Event Location: Other
• Date Report to Manufacturer: 09/25/2019
• Type of Device Usage: N
• Patient Sequence Number: 1