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

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem Computer Software Problem (1112)

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

Event Date 07/14/2020

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.The cse noted that results were not crossing to the centralink data management system.The system logs were evaluated, and the dms server logged the last communication of orders on (b)(6) 2020 at 11:44 p.M.The server logged the last communication of results on (b)(6) 2020 at 12:35 a.M., and the log indicated a tcp/ip socket error.The system was restarted, and the issue monitored.The cse and customer noted that patient results were crossing to the centralink data management system, and the issue was solved.The customer confirmed that all communications have worked as specified since 5:31 a.M.On (b)(6) 2020.This instrument has performed according to specifications, and no further evaluation of this device was required.

Event Description

The operator of the centralink data management system informed siemens that all communication stopped and caused a delay in testing and reporting results.The customer has not informed the length of the delay, and samples and tests that were affected.There are no known reports of adverse health consequences due to the loss of communication by the system.

• Brand Name: CENTRALINK DATA MANAGEMENT SYSTEM
• Type of Device: CENTRALINK DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown, ny
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; registration number: 8020888; chapel lane; swords co., dublin ; EI
• Manufacturer Contact: rolando hualpa ; 511 benedict avenue; tarrytown, ny ; 5242963
• MDR Report Key: 10382175
• MDR Text Key: 209432784
• Report Number: 2432235-2020-00362
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/07/2020

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
• Device Catalogue Number: 11312087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/07/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1