MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG PRIMARY CONSOLE 1ST GEN

Model Number 201-30100

Device Problems Thermal Decomposition of Device (1071); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/09/2018

Event Type  Injury  

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 during preventive maintenance of the primary console, the unit could be turned on; however, it would turn off on its own even after the battery was replaced.A burning smell and smoke was observed.The unit was immediately disconnected from ac power and the board was disconnected.The device was not in use on a patient at the time of the event.No additional information was provided.

Manufacturer Narrative

Investigation conclusion: the report of a primary console not powering on and a "burning smell" was confirmed and reproduced during testing of the returned centrimag primary console (serial number (b)(4)).The returned console was evaluated and tested by the service depot.The unit was inspected and found to have a burnt smell.Further analysis revealed that the main printed circuit board (pcb) and the motor controller pcb had component damage.Additional testing of the console revealed an open fuse (component f2) in the battery path of the main pcb and a burned power switch (component u203) on the lmcebp pcb.The root cause of this damage could not be conclusively determined during the investigation.Due to no replacement parts being available the unit could not be repaired and was scrapped.Reports of similar events will continue to be tracked and monitored.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG PRIMARY CONSOLE 1ST GEN
• 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: 7552491
• MDR Text Key: 109514904
• Report Number: 2916596-2018-02235
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K093832
• 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: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30100
• Device Catalogue Number: 201-30100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1