MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. T-LINK DATA MANAGEMENT SYSTEM

Model Number 814851

Device Problems Failure to Power Up (1476); Electrical Shorting (2926)

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

Event Date 04/24/2014

Event Type  malfunction  

Event Description

It was reported that during set-up of the device for a cardiopulmonary bypass procedure, the user powered up the system in the morning, took a break and came back, the t-link screen was blank and would not power up.As a result, an alternate device was employed.The surgical procedure was completed successfully.There were no delays, no blood loss, or no adverse consequences to the patient.

Manufacturer Narrative

The reported complaint was confirmed.Per laboratory evaluation, the technician confirmed the reported issue.The power light came on but no display.The monitor was functional, booted successfully into windows xp.Using a flashlight, the technician could see the desktop display, so only the backlight failed.There were signs of excessive current draw on the power cable that connects to the backlight inverter board.Per electrical engineer assessment of the manufacturing specification document: the inverter is bumping up the voltage to 1200 volts at room temperature to light the display.The browning of the connector is expected due to the heat from the high voltage level and the connector is flame retardant.The melted wire is most likely a power shortage.The product will be sent to service to be brought to manufacturers specifications before being returned to the customer.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: T-LINK DATA MANAGEMENT SYSTEM
• Type of Device: T-LINK DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 4001915
• MDR Text Key: 4774353
• Report Number: 1828100-2014-00532
• Device Sequence Number: 1
• Product Code: DXJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 814851
• Device Catalogue Number: 814851
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/30/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1