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

Model Number CENTRALINK DATA MANAGEMENT SYSTEM

Device Problem Smoking (1585)

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

Event Date 12/27/2021

Event Type  malfunction  

Manufacturer Narrative

A united states (us) customer contacted a siemens customer care center (ccc) to report that smoke emitted from the monitor attached to the centralink data management system (centralink configured high capacity server kit).A siemens customer service engineer (cse) was dispatched to the customer's site.The cse ordered a new monitor, which was delivered on 28 dec-2021, and the customer received the monitor.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

The customer reported that the monitor attached to a centralink data management system (centralink configured high capacity server kit) displayed wavy lines and then went blank.The customer reported that smoke emitted from the monitor at the time of the event.Subsequently, the customer unplugged the monitor.There was no harm to the user and there were no reports of delays in processing patient samples.There are no known reports of adverse health consequences due to the event.

• Brand Name: CENTRALINK DATA MANAGEMENT SYSTEM
• Type of Device: CENTRALINK DATA MANAGEMENT SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LTD; registration number: 8020888; chapel lane; swords, dublin, 10040 ; EI 10040
• Manufacturer Contact: douglas stanton ; 511 benedict ave; tarrytown, NY 10591 ; 9142706592
• MDR Report Key: 13308971
• MDR Text Key: 284137072
• Report Number: 2432235-2022-00007
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/20/2022

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: 10811744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2021
• Initial Date FDA Received: 01/20/2022
• 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