MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CI 1900 ANALYZER

Model Number	ATELLICA CI 1900 ANALYZER
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a burning smell, and sparks were coming from the boxes at the back of an atellica ci 1900 analyzer.The power block connection to the monitor was loose, causing heat and sparks.There was no injury, and no visible flame or smoke due to the event.There are no known reports of adverse health consequences due to the reported event.
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc) and reported a burning smell, and sparks were coming from the boxes at the back of an atellica ci 1900 analyzer.The customer shut down the analyzer.A siemens customer service engineer (cse) was dispatched to the customer¿s site.During the visit, the cse disconnected the monitor, and the breaker for the monitor and router remained engaged.Further, the cse installed a temporary external monitor on a table next to the system and restored full operation.Next, the cse replaced the monitor, power cord, and power cable.Siemens evaluated the event and determined that a loose power connection that could have been bumped during the service intervention potentially contributed to the reported event.The analyzer is performing within specifications.No further evaluation is required.

• Brand Name: ATELLICA CI 1900 ANALYZER
• Common Device Name: ATELLICA CI 1900 ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS MANUFACTURING LIMITED; chapel lane, swords, co.; registration number: 8020888; dublin ; EI
• Manufacturer Contact: varsha joshi ; pritech park sez, block 11; sarjapur outer ring road; karnataka 56010-3 ; IN 560103 ; 870577433
• MDR Report Key: 24842234
• Report Number: 2432235-2026-00093
• Device Sequence Number: 21066802
• Product Code: JJE
• UDI-Device Identifier: 00630414229553
• UDI-Public: (01)00630414229553
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K222116
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/10/2026

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
• Operator of Device: Health Professional
• Device Model Number: ATELLICA CI 1900 ANALYZER
• Device Catalogue Number: 10947347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown