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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 201-30300
Device Problems Disconnection (1171); Connection Problem (2900)
Patient Problem No Patient Involvement (2645)
Event Date 09/09/2019
Event Type  Injury  
Manufacturer Narrative
No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
It was reported that motor disconnect m2 alarm was observed during the self-check. The system was turned off, and replugged both motor and flow probe. The m2 alarm still returned even when switching to another motor. There was no problem with the first motor when connected to a different console.
 
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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 CH-80 05
SZ CH-8005
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key9150951
MDR Text Key162451736
Report Number2916596-2019-04487
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeTW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number201-30300
Device Catalogue Number201-30300
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/10/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/25/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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