MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR CP; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number	10309710
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported an odor emanating from the uninterruptible power supply (ups) that the advia centaur cp analyzer was plugged into.The customer reported that the system operator immediately called the it department of the site and the it representative removed the ups and provided a temporary ups.The customer also noted that it personnel took the affected ups away and so the customer does not have the make and model of the ups available.The customer also reported that the it personnel took a temperature measurement of the body of the ups unit shortly after the overheating event and at that time the ups temperature was reading at 200 degrees fahrenheit.A siemens customer service engineer (cse) was dispatched to the customer site to inspect the analyzer.The cse replaced the ups, resolving the behavior.The cause of the odor and smoke was an overheated ups.The analyzer is performing within specifications.No further evaluation of this analyzer is needed.
Event or Problem Description
The customer reported an odor emanating from the uninterruptible power supply (ups) that the advia centaur cp was plugged into.A small amount of smoke was observed from the ups.The advia centaur cp was not in use when the ups over heated.There are no reports of a delay in testing, no reports of discordant test results and no reports of injury.

• Brand Name: ADVIA CENTAUR CP
• Common Device Name: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY
• Manufacturer (Section G): STRATEC BIOMEDICAL SWITZERLAND AG; neuwiesenstrasse 4; registration #: 3008494306; beringen ; SZ
• Manufacturer Contact: karl aebig ; 511 benedict ave.; tarrytown, NY 10591 ; 9142550572
• MDR Report Key: 23732865
• Report Number: 2432235-2025-00308
• Device Sequence Number: 13402429
• Product Code: JJE
• UDI-Device Identifier: 00630414523286
• UDI-Public: (01)00630414523286
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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): 12/05/2025

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: 10309710
• Device Catalogue Number: 10309710
• 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: 11/22/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown