MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. CENTRALINK DATA MANAGEMENT SYSTEM

Model Number CENTRALINK DATA MANAGEMENT SYSTEM HIGH END SERVER

Device Problem Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2021

Event Type  malfunction  

Manufacturer Narrative

A customer in the united states contacted siemens to report that a centralink data management system high end server was emitting smoke.A siemens customer service engineer (cse) was dispatched to the customer site to inspect the centralink device.The cse found that the plastice face of the device, where a hard drive and cd player are mounted, showed evidence of melting and heat damage.The cse did not repair the centralink because the customer is replacing the centralink with the atellica data manager.The cause of the smoke is unknown.The device was removed from service.No further investigation of the device is needed.

Event Description

A centralink data management system high end server (centralink) was reportedly emitting smoke.The customer powered down the centralink.There are no reports of sparks or open flame.There are no known reports of patient intervention or adverse health consequences due to the event.

• Brand Name: CENTRALINK DATA MANAGEMENT SYSTEM
• Type of Device: CENTRALINK
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 12594719
• MDR Text Key: 283958052
• Report Number: 2432235-2021-00244
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CENTRALINK DATA MANAGEMENT SYSTEM HIGH END SERVER
• Device Catalogue Number: 10282198
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1