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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

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THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS Back to Search Results
Model Number L201-90411
Device Problem Power Problem (3010)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/16/2014
Event Type  malfunction  
Manufacturer Narrative
Patient information was not provided. The device was returned for investigation. The evaluation is not yet completed. No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
The patient was being supported with an extracorporeal circulatory support pump. It was reported that the centrimag console displayed the b6 error code even though the unit was connected to wall power. No further information regarding the event was provided.
 
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Brand NameCENTRIMAG 2ND GENERATION PRIMARY CONSOLE
Type of DeviceCONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CH-80 05
SZ CH-8005
Manufacturer (Section G)
THORATEC SWITZERLAND GMBH
technoparkstrasse 1
zurich CA CH-80 05
SZ CH-8005
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key8302626
MDR Text Key136803575
Report Number2916596-2019-00353
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 02/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/04/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Model NumberL201-90411
Device Catalogue NumberL201-90411
Device Lot Number6462258
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/28/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/12/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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