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

Model Number 201-90411

Device Problem Failure to Power Up (1476)

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

Event Date 04/24/2019

Event Type  Injury  

Manufacturer Narrative

No patient involved.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported there was an s1 - power on test fail alarm system error which took place on ac power.When power cycled the unit persisted with the alarm.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of a power on test fail:s1 alarm was confirmed and reproduced during testing of the returned centrimag 2nd gen primary console (sn (b)(4)).The returned console was evaluated and tested at mcs zurich.The console was connected to a test mag monitor and mains supply and then powered on.During boot-up the console failed self-test with error "power on self-test fails:s1", confirming and reproducing the reported event.Next, the console was opened for inspection.No noticeable issues were seen.While open, the console was turned on and allowed to run through the self-test.This time, the self-test passed, which shows that the issue is intermittent.With the self-test passing, the console was connected to the monitor and a log file was downloaded.The console's log file showed a power button fault.On (b)(6) 2019 sub-fault "sf_sps_power_button_inconsistent" occurred and triggered the alert "power on self-test fail:s1".With this fault identified, the power button assembly was replaced with a new one.Once the defective power button assembly was replaced the issue did not re-occur.The damaged housing and front overlay were replaced with new components.The console was then re-processed according to the repair and maintenance procedure the unit passed all tests.The repaired and tested unit was forwarded to burlington service depot for final processing and disposition.The root cause of the defective power button assembly could not be conclusively determined during the investigation.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 CA 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 Key: 8604170
• MDR Text Key: 144840145
• Report Number: 2916596-2019-02176
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 6512453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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