MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 1600 ANALYZER

Model Number	ATELLICA IM 1600 ANALYZER
Medical Device Problem Codes	Melted (1385); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A siemens customer service engineer (cse) reported melted power cord plugs were observed on an atellica im 1600 analyzer due to water that had dropped on the plugs.There is no safety protection to cut off the power in case of a leak.There was visible damage to the power cord plugs as a result of the event.There are no known reports of adverse health consequences due to the event.
Additional Manufacturer Narrative
An outside of the united states (ous) customer service engineer (cse) contacted a siemens customer care center to report melted power cord plugs were observed on an atellica im 1600 analyzer.The customer service engineer (cse) was dispatched to the customer site.The cse disconnected the power plug and replaced both the female and male connection.Siemens is investigating the event.
Additional Manufacturer Narrative
Siemens filed the initial mdr 2432235-2025-00324, on 30-dec-2025.Additional information (30-jan-2026): siemens further evaluated the event by reviewing the available information in the complaint and concluded that the probable cause of the event was consistent with a use error.It was found that at the customer site, the power cable of the atellica im 1600 analyzer is connected with an extension cord which was routed under a neighboring atellica ch 930 analyzer to reach a power source.The use of an extension cord is an unsupported configuration.In this analyzer and power cable configuration, the neighboring atellica ch 930 had an instrument leak.The neighboring atellica ch 930 leaked wastewater onto the electrical cable connection between the atellica 1600 power cable and the extension cord cable.The water from the leak dripped directly on the connection plugs.Because the power cable is not waterproof, the combination of water and electricity created a current leakage in the water puddle under the analyzer.Heat from the current leakage caused the plug to melt.The complaint was resolved with routine troubleshooting actions.The customer is operational.The investigation conclusions code in section h6 was updated to reflect the additional information.No further evaluation of this analyzer is required.

• Brand Name: ATELLICA IM 1600 ANALYZER
• Common Device Name: ATELLICA IM 1600 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: sumaiya rajpura ; 511 benedict ave.; tarrytown, NY 10591 ; 5513306538
• MDR Report Key: 23920861
• Report Number: 2432235-2025-00324
• Device Sequence Number: 9029606
• Product Code: JJE
• UDI-Device Identifier: 00630414002026
• UDI-Public: (01)00630414002026
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K151792
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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 IM 1600 ANALYZER
• Device Catalogue Number: 11066000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2020
• 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