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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE

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THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE Back to Search Results
Model Number 201-30300
Device Problems Smoking (1585); Power Problem (3010)
Patient Problem No Patient Involvement (2645)
Event Date 06/15/2018
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for analysis. It has not yet been received. No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
It was reported that smoke came out from the ac wall socket when the primary console was plugged in, and thereby the wall fuse shut off. The primary console was in charging mode when the issue occurred. The device was not in use on a patient at the time of the event. No additional information was provided.
 
Manufacturer Narrative
Unique identifier (udi) # (device identifier): device was manufactured prior to the udi labeling implementation. Corrected data. It was initially reported that the device was returning for analysis; however, the device was not returned. No product was returned for evaluation. Evaluation of the submitted photo confirmed burn marks on the ac connector, consistent with the report of smoke; however, a specific cause could not conclusively be determined through this evaluation. No further information was provided. The manufacturer is closing the file on this event.
 
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Brand NameCENTRIMAG 2ND GENERATION PRIMARY CONSOLE
Type of DevicePRIMARY CONSOLE
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 Key7686174
MDR Text Key114409533
Report Number2916596-2018-02538
Device Sequence Number1
Product Code DWA
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number201-30300
Device Catalogue Number201-30300
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/15/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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