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

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem Mechanical Problem (1384)

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

Event Date 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center and stated that after rebooting the centralink server they obtained an "invalid" license message when launching the centralink application and required new activation codes.A siemens regional support center (rsc) specialist determined that the customer misunderstood that license was necessary to run communication service on the centralink.However, because of network issue the centralink server established a new server identifier requiring new licenses and activation codes.The rsc specialist explained the situation to the customer and restarted all the services and translators.Later, the rsc specialist remotely implemented the new activation codes on the centralink system, which were built based on the new server id.A siemens customer service engineer (cse) was dispatched to the customer site.After analyzing the system, the cse found a hardware error on the first nic (local area connection), which was used to build the previous server id.The cse confirmed that the network incident was resolved by replacing the network switch used to connect the centralink system to the automation and analyzers.The device is performing as expected.No further evaluation of device is required.

Event Description

The customer of a centralink data management system reported that after rebooting the centralink server they obtained an "invalid" license message when launching the centralink application.The laboratory activity was interrupted for about six hours.There was delay in reporting of patients results including the stat samples.There are no known reports of patient intervention or adverse health consequence due to the delay in reporting of results.

• Brand Name: CENTRALINK DATA MANAGEMENT SYSTEM
• Type of Device: DATA MANAGER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; manufacturing limited; registration number: 8020888; chapel lane, swords, co., dublin 10040 ; EI 10040
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6547411
• MDR Text Key: 74600878
• Report Number: 2432235-2017-00305
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2017
• Initial Date FDA Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: No
• 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