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U.S. Department of Health and Human Services

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

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BAYER MEDICAL CARE INC MEDRAD PRESSURE INJECTOR INJECTOR, CONTRAST MEDIUM, AUTOMATIC Back to Search Results
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.
 
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Brand NameMEDRAD PRESSURE INJECTOR
Type of DeviceINJECTOR, CONTRAST MEDIUM, AUTOMATIC
Manufacturer (Section D)
BAYER MEDICAL CARE INC
1 bayer drive
indianola PA 15051
MDR Report Key9117593
MDR Text Key160030316
Report Number9117593
Device Sequence Number1
Product Code IZQ
Combination Product (y/n)N
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received09/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/23/2019
Event Location Other
Date Report to Manufacturer09/25/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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