• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SIEMENS HEALTHCARE DIAGNOSTICS INC. CENTRALINK DATA MANAGEMENT SYSTEM Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key13308971
MDR Text Key284137072
Report Number2432235-2022-00007
Device Sequence Number1
Product Code JQP
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 NumberCENTRALINK DATA MANAGEMENT SYSTEM
Device Catalogue Number10811744
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/27/2021
Initial Date FDA Received01/20/2022
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 Number1
-
-