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

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem Device Issue (2379)

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

Event Date 02/28/2017

Event Type  malfunction  

Manufacturer Narrative

A siemens headquarters support center (hsc) specialist reviewed the event.Hsc found the cerberus connection timed out before the upgrade.This caused the images to not transfer immediately.The centralink service was rebooted ten (10) times.After the last reboot, the server started and an image was accepted.The cause of the delay in receiving hematology images was due to the cerberus connection timed out before the upgrade.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

The customer reported that images from their hematology instruments, from a remote site, were delayed after an update and reboot of the centralink system.The application cerberus, did not see the hospital connection, which is what is used by the remote site to send files.There are no known reports of patient intervention or adverse health consequences due to the delay in receiving hematology images.

• 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 DIAGNOSTICSMANUFACTURING LTD; registration #: 8020888; chapel lane; swords, co, dublin 10040 ; EI 10040
• Manufacturer Contact: timothy rice ; 511 benedict ave; tarrytown, NY 10591 ; 9145242406
• MDR Report Key: 6437860
• MDR Text Key: 70990916
• Report Number: 2432235-2017-00221
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/27/2017

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: 03/02/2017
• Initial Date FDA Received: 03/27/2017
• 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