MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE SYSTEM MONITOR II; VENTRICULAR (ASSISST) BYPASS

Model Number 1286A

Device Problem Display or Visual Feedback Problem (1184)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that system monitor had a white screen.Additional information stated the system came for investigation and it was found that the screen was not responding and the main board was damaged and had to be replaced.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event, of a system monitor with a non-functional screen - blank/white screen, was confirmed when the unit was evaluated by technical service.Replacing the main pcb assembly (main board) resolved the issue.The repaired system monitor was tested, passed and returned to the customer.The removed main board operated properly when checked on a reference system.The blank/white screen did not appear and was not duplicated ¿ with multiple power ups.The display data was present, updating and clear.The screen was responsive to touch commands.The board was installed into the system monitor was originally built ¿ over 13 years ago.The system monitor (pn 101214) was built in 05feb2007.The packaged system monitor (pn 1286a) was placed into inventory on 07feb2007.The unit was sent to tel on 06mar2007.The unit was sent to the distributor (pro buono ltd / lithuania) in mar2007.The unit was customer owned.The unit was last serviced on 03oct2019.The main pcb assembly (main board) was installed in the system monitor when it was built (feb2007).Setup and use of the system monitor with the heartmate power module are documented in the heartmate power module instructions for use (ifu)(setting up the system monitor for use with the power module) and heartmate 3 lvas ifu (system monitor setup).No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE SYSTEM MONITOR II
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11025077
• MDR Text Key: 222028714
• Report Number: 2916596-2020-06122
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1286A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1