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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BACK-UP CONSOLE WITH BATTERIES CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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THORATEC SWITZERLAND GMBH CENTRIMAG BACK-UP CONSOLE WITH BATTERIES CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Device Problem Disconnection (1171)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/07/2017
Event Type  malfunction  
Event Description
Multiple consoles have shown motor disconnected when the centrimag pump is connected to the console. Pt was at home on the heart device (ventricular assist device).
 
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Brand NameCENTRIMAG BACK-UP CONSOLE WITH BATTERIES
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
6035 stoneridge drive
pleasanton CA 94588
MDR Report Key9255239
MDR Text Key164276307
Report Number9255239
Device Sequence Number1
Product Code DWA
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 10/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/10/2019
Event Location Other
Date Report to Manufacturer10/30/2019
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? No
Type of Device Usage

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