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

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.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: PRIMARY 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 Key: 7686174
• MDR Text Key: 114409533
• Report Number: 2916596-2018-02538
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30300
• Device Catalogue Number: 201-30300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1